1174 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices

IV. Electronic Access interested in pursuing their requests, drugs to be marketed without Persons with access to the Internet and will deem the requests withdrawn. independent approval. may obtain the document at http:// DATES: Effective Date: This notice is In 1962, Congress amended the act to www.fda.gov/BiologicsBloodVaccines/ effective February 7, 2011. Hearing require that new drugs be proven GuidanceCompliance requests must be affirmed by notifying effective for their labeled indications, as RegulatoryInformation/default.htm, FDA by February 7, 2011. Hearing well as safe, in order to obtain FDA approval. This amendment also http://www.fda.gov/Drugs/ requests not affirmed within that time necessitated that FDA conduct a GuidanceCompliance frame will be deemed withdrawn. retrospective evaluation of the RegulatoryInformation/Guidances/ ADDRESSES: All communications in effectiveness of the drug products that default.htm, http://www.fda.gov/ response to this notice should be FDA had approved as safe between 1938 MedicalDevices/DeviceRegulationand identified with the appropriate docket and 1962. FDA contracted with the Guidance/GuidanceDocuments/ number, and directed to the appropriate National Academy of Science/National default.htm, and http:// office listed as follows: Research Council (NAS/NRC) to make www.regulations.gov. To affirm or withdraw hearing requests: Sakineh Walther, Center for an initial evaluation of the effectiveness Dated: January 1, 2011. Drug Evaluation and Research, Food of over 3,400 products that had been Leslie Kux, and Drug Administration, 10903 New approved only for safety between 1938 Acting Assistant Commissioner for Policy. Hampshire Ave., Bldg. 51, rm. 5242, and 1962. The NAS/NRC reports for [FR Doc. 2011–73 Filed 1–6–11; 8:45 am] Silver Spring, MD 20993–0002. these drug products were submitted to BILLING CODE 4160–01–P All other communications: Sakineh FDA in the late 1960s and early 1970s. Walther, Center for Drug Evaluation and The agency reviewed and re-evaluated Research, Food and Drug the reports and published its findings in DEPARTMENT OF HEALTH AND Administration, 10903 New Hampshire Federal Register notices. FDA’s HUMAN SERVICES Ave., Bldg. 51, rm. 5242, Silver Spring, administrative implementation of the MD 20993–0002. NAS/NRC reports was called the Drug Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Efficacy Study Implementation (DESI). [Docket Nos. FDA–1981–N–0361 (formerly Sakineh Walther, Center for Drug DESI covered the approximately 3,400 81N–0391), FDA–1981–N–0077 (formerly Evaluation and Research, Food and products specifically reviewed by the 81N–0393), FDA–1981–N–0248 (formerly Drug Administration, 10903 New NAS/NRC, as well as the even larger 81N–0396), FDA–1982–N–0225 (formerly Hampshire Ave., Bldg. 51, rm. 5242, number of IRS products that entered the 82N–0078), FDA–1982–N–0046 (formerly Silver Spring, MD 20993–0002, 301– market without FDA approval. 82N–0095), FDA–1982–N–0264 (formerly 796–3349, e-mail: In the early 1970s, FDA granted 82N–0096), FDA–1982–N–0310 (formerly 3 [email protected]. temporary exemptions from the time 82N–0311), and FDA–1983–N–0137 limits established 4 for completing (formerly 83N–0095); DESI 5213, 6290, 6303, SUPPLEMENTARY INFORMATION: 6514, 8658, 11935, and 12152] certain phases of the DESI program for I. Background certain oral prescription drugs offered Drugs for Human Use; Drug Efficacy When initially enacted in 1938, the for relief of cough, cold, allergy, and Study Implementation; Oral Federal Food, Drug, and Cosmetic Act related symptoms. The exemptions were Prescription Drugs Offered for Relief of (FD&C act) required that ‘‘new drugs’’ be granted because of the close relationship Symptoms of Cough, Cold, or Allergy; approved for safety by FDA before they between these prescription drugs and Withdrawal of Hearing Requests; could legally be sold in interstate drugs sold over the counter (OTC) that Opportunity To Affirm Outstanding commerce.1 To this end, the FD&C Act were subject to the ongoing OTC drug Hearing Requests; Final Resolution of made it the sponsor’s responsibility, review (see 21 CFR part 330). Dockets prior to marketing a new drug, to submit Postponement of final evaluations of a new drug application (NDA) to FDA these DESI prescription products ACTION: Notice. to prove that its drug was safe. Between enabled the agency to consider the recommendations of the OTC review SUMMARY: 1938 and 1962, if a drug obtained The Food and Drug panel in addition to any evidence Administration (FDA) is announcing approval, FDA considered drugs that were identical, related, or similar (IRS) 2 submitted by NDA holders and other that all outstanding hearing requests parties in response to various DESI pertaining to Docket Nos. 81N–0391, to the approved drug to be ‘‘covered’’ by that approval, and allowed those IRS notices covering relevant products. 82N–0078, and 82N–0311 have been All drugs covered by the DESI review withdrawn and therefore, shipment in are ‘‘new drugs’’ under the FD&C Act. If interstate commerce of the products 1 A ‘‘new drug’’ is defined by the FD&C Act as a drug that ‘‘is not generally recognized, among FDA’s final DESI determination identified in those dockets, or any experts qualified by scientific training and classifies a drug product as lacking identical, related, or similar product experience to evaluate the safety and effectiveness substantial evidence of effectiveness for that is not the subject of an approved of drugs, as safe and effective for use under the one or more indications, that drug new drug application (other than an conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not product and those IRS to it may no over-the-counter (OTC) product that so recognized shall not be deemed to be a ‘new longer be marketed for such indications complies with an applicable OTC drug’ if at any time prior to the enactment of this and are subject to enforcement action as monograph), is unlawful as of the FD&C Act it was subject to the Food and Drugs Act unapproved new drugs. If FDA’s final effective date of this notice. FDA is also of June 30, 1906, as amended, and if at such time its labeling contained the same representations DESI determination classifies the drug offering an opportunity to affirm concerning the conditions of its use * * *.’’ (21 product as effective for one or more of outstanding hearing requests in Docket U.S.C. 321(p)). its labeled indications, the drug can be Nos. 81N–0393, 81N–0396, 82N–0095, 2 Section 310.6(b)(1) (21 CFR 310.6(b)(1)) marketed for such indications, provided 82N–0096, and 83N–0095. FDA will provides: ‘‘An identical, related, or similar drug includes other brands, potencies, dosage forms, assume that companies with salts, and esters of the same drug moiety as well as 3 38 FR 34481 (December 14, 1973). outstanding hearing requests that do not of any drug moiety related in chemical structure or 4 38 FR 4006 (February 9, 1973) and 37 FR 15022 respond to this notice are no longer known pharmacological properties.’’ (July 27, 1972).

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1175

it is the subject of an application and Boots Pharmaceuticals, Inc., 6540 opportunity for a hearing on a proposal approved for safety and effectiveness. Line Ave., Shreveport, LA 71106–9989, to withdraw approval of the NDAs for Sponsors of drug products that have for its product IRS to Omni-Tuss those indications. been found to be effective for one or Suspension. Hycodan Syrup, Tablets, and Powder, more indications through the DESI Pennwalt, the NDA holder for Omni- containing hydrocodone bitrartrate and process may rely on FDA’s effectiveness Tuss Suspension, did not request a homatropine methylbromide, were determinations, but typically must hearing for that product. On May 24, marketed under NDA 5–213. Benadryl update their labeling to conform to the 1983 (48 FR 23311), FDA announced with Ephedrine Sulfate Kapseal, indications found to be effective by FDA that it was withdrawing approval of containing diphenhydramine and to include any additional safety NDA 12–666, effective June 23, 1983. hydrochloride and ephedrine sulfate, information required by FDA. Those On February 29, 1988, Pennwalt was marketed under NDA 5–845. Chlor- drug products with NDAs approved withdrew its hearing request for the Trimeton Repetabs Tablets, containing before 1962 for safety therefore require Tussionex products, following approval 12 milligrams (mg) chlorpheniramine approved supplements to their original of a reformulation of the suspension maleate, were marketed under NDA applications if found to be effective product (NDA 19–111). On March 23, 7–638. PBZ Lontabs and PBZ–SR, under DESI; IRS drug products require 1988 (53 FR 9492), FDA announced it containing tripelennamine an approved NDA or abbreviated new was withdrawing approval of NDA hydrochloride, were marketed under drug application (ANDA), as 10–768, effective April 22, 1988. On NDA 10–533. Dimetane Extentabs, appropriate. Furthermore, labeling for May 23, 1988, Boots withdrew its containing brompheniramine maleate, drug products classified as effective may hearing request. was marketed under NDA 10–799. contain only those indications for which Thus, all outstanding hearing requests Hispril Spansule Capsules, containing the review found the product effective related to Docket 81N–0391 have now diphenylpyraline hydrochloride, was unless the firm marketing the product been withdrawn and, as stated marketed under NDA 11–945. Disophrol has received an approval for the previously, the approvals for NDA Tablets, containing additional indication(s). 10–768 and NDA 12–666 were dexbrompheniramine maleate and withdrawn in 1988 and 1983, pseudoephrine sulfate, was marketed II. DESI Review of Oral Prescription respectively. Shipment in interstate under NDA 12–394. Novrad with A.S.A. Drugs Offered for Relief of Symptoms of commerce of the previously mentioned Pulvules, containing levopropoxyphene Cough, Cold, or Allergy products, or any IRS product that is not napsylate and aspirin, was marketed A. DESI Cough, Cold, or Allergy Dockets the subject of an approved NDA or under NDA 13–097. for Which Hearing Requests Have Been ANDA, is unlawful as of the effective In response to the June 1, 1982, notice, timely hearing requests were Withdrawn date of this notice. This notice is not filed by Cord Laboratories, Inc., 2555 W. applicable to OTC products that comply 1. Tussionex Tablets and Suspension Midway Blvd., Broomfield, CO 80020, with an OTC monograph (21 CFR and Omni-Tuss Suspension, Docket for its IRS products Chlorpheniramine 310.6(f)). Any person who wishes to 81N–0391 (DESI 6514) Maleate S.R. Capsules and Efedra-PA determine whether a specific product is Tablets, and KV Pharmaceutical Co., In a notice published in the Federal covered by this notice should write to 2503 South Hanley Rd., St. Louis, MO Register on May 25, 1982 (47 FR 22606), the Center for Drug Evaluation and 63144, for its IRS products FDA revoked the temporary exemption Research (address given previously). that permitted the drug products chlorpheniramine maleate sustained described below, and those products 2. Hycodan Syrup, Tablets, and Powder; release capsules, 8 and 12 mg. A late IRS to these products, to remain on the Benadryl With Ephedrine Sulfate hearing request was filed by Sidmak market beyond the time limit Kapseal; Chlor-Trimeton Repetabs Laboratories, 17 West St., P.O. Box 371, established for DESI. The notice also Tablets; PBZ Lontabs and PBZ–SR; East Hanover, NJ 07936, for three IRS reclassified the products to lacking Dimetane Extentabs; Hispril Spansule products: Chlorpheniramine maleate 8 substantial evidence of effectiveness, Capsules; Disophrol Tablets; and mg.; chlorpheniramine maleate 12 mg; and offered an opportunity for a hearing Novrad with A.S.A. Pulvules; Docket and a dexbrompheniramine maleate and on a proposal to withdraw approval of 82N–0078 (DESI 5213, 6290, 6303, 8658, pseudoephedrine sulfate product. NDAs 5–213, 5–845, and 7–638 have the NDAs for the products. 11935) not been withdrawn, but the products Tussionex Tablets and Suspension, In a notice published in the Federal marketed under NDA 5–213 and NDA both containing dihydrocodeinone and Register on June 1, 1982 (47 FR 23809), 7–638 have been discontinued, and the phenyltoloxamine dihydrogen sulfate, FDA revoked the temporary exemption oral Benadryl products associated with were marketed under NDA 10–768, and that permitted the drug products NDA 5–845 are marketed with labeled as antitussives. Omni-Tuss described below, and those products indications that are consistent with the Suspension, containing codeine sulfate, IRS to these products, to remain on the OTC monograph, 21 CFR part 341. phenyltoloxamine dihydrogen sulfate, market beyond the time limit NDAs 10–533, 10–799, 11–945, and chlorpheniramine maleate, ephedrine established for DESI. The notice also 12–394 were voluntarily withdrawn on sulfate, and guaiacol carbonate, was reclassified the products to lacking November 7, 2007 (72 FR 62858), June marketed under NDA 12–666, and was substantial evidence of effectiveness for 16, 2006 (71 FR 34940), March 21, 1994 also labeled as an antitussive. certain indications, and offered an (59 FR 9989), and October 9, 1986 In response to the May 25, 1982, (51 FR 36295), effective on December 7, notice, timely hearing requests were contained in the hearing requests. In some cases, 2007, June 16, 2006, April 1, 1994, and filed by Pennwalt Corp., 755 Jefferson the companies requesting hearings identified the November 10, 1986, respectively. On Rd., Rochester, NY 14623, for its product that was the subject of the hearing request by name. In other cases, the company simply June 7, 1977, FDA announced that it products marketed under NDA 10–768 5, identified the subject of its hearing request as a was withdrawing approval of NDA product that is IRS to one of the products reviewed 5 This Federal Register notice identifies the under DESI. In yet other cases, there is no 13–097, effective June 13, 1977, for products that are the subjects of hearing requests to information provided by the requester about the failure to file required reports (42 FR the extent possible based on the information product that is the subject of its hearing request. 29104). NDA 13–097 was included in

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES 1176 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices

the June 1982 notice to inform On May 26, 1983, Lemmon Co. of the companies that requested manufacturers of IRS products of the withdrew its hearing request relating to hearings may no longer be in business, agency’s finding of effectiveness for the this docket. Sandoz, Inc., 2555 West FDA is seeking to determine whether product (42 FR 23809). Midway Blvd., Broomfield, CO 80020, there is continued interest in pursuing On October 21, 2009, the hearing the successor-in-interest to Cord these outstanding hearing requests. request filed by Cord Laboratories, Inc., Laboratories, Inc., withdrew its hearing Through this Federal Register notice, was withdrawn by its successor-in- request on October 21, 2009. On FDA seeks to have any company with an interest, Sandoz, Inc., 2555 West February 15, 2010, Teva outstanding hearing request covered by Midway Blvd., Broomfield, CO 80020. Pharmaceuticals, the successor-in- this notice that has not already On December 4, 2009, KV interest to Sidmak Laboratories, responded to a direct communication Pharmaceutical Co. also withdrew its withdrew its hearing request. Thus, all from FDA either withdraw or affirm its hearing request. On February 15, 2010, outstanding hearing requests related to hearing request. FDA will assume that Sidmak Laboratories’ hearing request Docket 82N–0311 have now been companies with outstanding hearing was withdrawn by its successor-in- withdrawn. NDAs 11–935 and 11–936 requests that do not respond to this interest, Teva Pharmaceuticals. Thus, all were withdrawn by FDA on November notice are no longer in business and/or outstanding hearing requests related to 28, 1997, effective December 29, 1997, do not have a continuing interest in the Docket 82N–0078 have now been following requests by the application hearings, and FDA will deem their withdrawn. holders. (62 FR 63347). requests withdrawn. Shipment in interstate commerce of Shipment in interstate commerce of To withdraw an outstanding hearing the previously mentioned products, or the previously mentioned products, or any IRS product that is not the subject request, a company (or its successor-in- any IRS product that is not the subject interest) or its representative should of an approved NDA or ANDA, is of an approved NDA or ANDA, is unlawful as of the effective date of this send a letter stating its intention to do unlawful as of the effective date of this so to the address provided above. The notice. This notice is not applicable to notice. This notice is not applicable to OTC products that comply with an OTC letter should include the docket number OTC products that comply with an OTC of the proceeding, as well as the name monograph (21 CFR 310.6(f)). Any monograph (21 CFR 310.6(f)). Any person who wishes to determine and NDC (National Drug Code) number person who wishes to determine whether a specific product is covered by of the product that is the subject of the whether a specific product is covered by this notice should write to the Center for hearing request. this notice should write to the Center for Drug Evaluation and Research (address To affirm an outstanding hearing Drug Evaluation and Research (address given above). request, a company (or its successor-in- given previously). interest), or its representative should B. DESI Cough, Cold, or Allergy Dockets 3. Actifed Syrup and Tablets; Docket send a letter stating its intention to do With Outstanding Hearing Requests 82N–0311 (DESI 11935) so to the address provided previously. In 2006, FDA announced a new drug The letter should include the docket In a notice published in the Federal safety initiative to address unapproved number of the proceeding, as well as the Register on October 22, 1982 (47 FR drugs currently being marketed in the name and NDC number of the product 47085), FDA revoked the temporary United States, and to facilitate a rational that is the subject of the hearing request. exemption that permitted the drug process to bring all such unapproved Letters affirming outstanding hearing products described below, and those drugs into the approval process. As part requests must be postmarked or e- products IRS to these products, to of the Unapproved Drugs Initiative, the mailed within 30 calendar days of the remain on the market beyond the time Office of Compliance of the Center for date of this notice. Only currently limit established for DESI. In the notice, Drug Evaluation and Research is outstanding hearing requests may be FDA also announced the conditions for reviewing proceedings that remain open affirmed; this notice does not provide a marketing these products for the under DESI. According to FDA’s new opportunity to request a hearing indication for which they were regarded records, the dockets discussed below under any of these dockets. as effective, and offered an opportunity contain pending hearing requests. In for a hearing concerning a proposal to cases where FDA was able to obtain 1. Phenergan Expectorant With Codeine, withdraw approval of the NDAs for the current contact information for a Phenergan VC Expectorant Plain, indications reclassified to lacking company (or its successor-in-interest) or Phenergan VC Expectorant With substantial evidence of effectiveness. its representative, FDA sent letters Codeine, Phenergan Expectorant Plain, Actifed Syrup and Tablets both directly to the companies (or their and Pediatric Phenergan Expectorant contained triprolidine hydrochloride successors-in-interest) and/or their With Dextromethorphan; Docket 81N– and pseudoephedrine hydrochloride, representatives requesting that 0393 (DESI 6514) and were marketed under NDA 11–935 outstanding hearing requests be In a notice published in the Federal and NDA 11–936, respectively. withdrawn or affirmed within a Register on May 25, 1982 (47 FR 22610), In response to the October 22, 1982, specified time frame. In some cases, FDA revoked the temporary exemption notice, timely hearing requests were however, FDA was unable to find that permitted the drug products filed by Cord Laboratories, Inc., 2555 current contact information for the described below, and those products West Midway Blvd., Broomfield, CO companies that requested hearings. IRS to these products, to remain on the 80020, for its IRS products Corphed Because many of the products that are market beyond the time limit Syrup and Tablets, and Lemmon Co., the subjects of these hearing requests established for DESI. The notice also 850 Cathill Rd., Sellersville, PA 18960, may no longer be marketed 6 and some reclassified the products to lacking for its IRS products Tri-Fed and substantial evidence of effectiveness, Actiprem. A late hearing request was 6 For example, many of the products covered by and offered an opportunity for a hearing filed by Sidmak Laboratories, Inc., 17 these dockets, as originally formulated or as reformulated, contain phenylpropanolamine (PPA). West St., P.O. Box 371, East Hanover, NJ In 2001, FDA proposed to withdraw several new hemorrhagic stroke (66 FR 42665, August 14, 2001). 07936, for its product IRS to Actifed drug applications for products containing PPA, due FDA believes products containing PPA are no Tablets. to evidence that the ingredient increases the risk of longer being marketed.

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1177

on a proposal to withdraw approval of Ave., Elizabeth, NJ 07207, for IRS on a proposal to withdraw approval of the NDAs for the products. products Promethazine HCl Expectorant the NDAs for the products. Phenergan Expectorant With Codeine, VC with Codeine, Promethazine HCl Dimetane Expectorant, containing containing promethazine hydrochloride, Expectorant Plain, and Promethazine brompheniramine maleate, ipecac fluidextract, potassium HCl Expectorant with Codeine; and phenylephrine hydrochloride, guaiacolsulfonate, citric acid, sodium Wyeth Laboratories, P.O. Box 8299, phenylpropanolamine hydrochloride, citrate, and codeine phosphate, was Philadelphia, PA 19101, the and guaifenesin, was marketed under marketed under NDA 8–306. Phenergan manufacturer of the Phenergan NDA 11–694. Dimetane Expectorant-DC, VC Expectorant Plain, containing products, for all five of the Phenergan containing codeine phosphate, promethazine hydrochloride, ipecac products considered under this docket. brompheniramine maleate, fluidextract, potassium On July 13, 1984, Wyeth, the holder phenylephrine hydrochloride, guaiacolsulfonate, citric acid, sodium of the NDAs for the Phenergan products, phenylpropanolamine hydrochloride, citrate, and phenylephrine withdrew its hearing request after and guaifenesin, was marketed under hydrochloride, was marketed under approval of reformulated versions of NDA 11–694. Actifed-C Expectorant, NDA 8–306. Phenergan VC Expectorant four of its five products. Accordingly, containing codeine phosphate, With Codeine, containing promethazine on August 15, 1984 (49 FR 32681), FDA triprolidine hydrochloride, hydrochloride, ipecac fluidextract, announced that it was withdrawing pseudoephedrine hydrochloride, and potassium guaiacolsulfonate, citric acid, approval of NDAs 8–306, 8–604, and guaifenesin, was marketed under NDA sodium citrate, phenylephrine 11–265 pertaining to the old 12–575. All of these products were hydrochloride, and codeine phosphate, formulations of the Phenergan products, marketed as expectorants. was marketed under NDA 8–306. effective September 14, 1984. On In response to the May 25, 1982, Phenergan Expectorant Plain, October 25, 1984, Cord also withdrew notice, timely hearing requests were containing promethazine hydrochloride, its hearing request relating to this filed by A.H. Robins Co., 1407 ipecac fluidextract, potassium docket, based on discontinuation of the Cummings Dr., Richmond, VA 23220, guaiacolsulfonate, citric acid, and products that were the subject of the for its products marketed under NDA sodium citrate, was marketed under hearing request. 11–694; Bay Laboratories, 3654 West NDA 8–604. Pediatric Phenergan FDA sent letters to Pfizer, Inc., 235 Jarvis, Skokie, IL 60076, for its IRS Expectorant With Dextromethorphan, East 42nd St., New York, NY 10017, products Triphen Expectorant, Triphen containing promethazine hydrochloride, successor to Lederle Laboratories, and to Expectorant DC, and Pseudodine ‘‘C’’ ipecac fluidextract, potassium Actavis, 60 Columbia Rd., Building B, Expectorant; Burroughs Wellcome Co., guaiacolsulfonate, citric acid, sodium Morristown, NJ 07960, successor to 3030 Cornwallis Rd., Research Triangle citrate, and dextromethorphan Purepac Pharmaceuticals, on November Park, NC 27709, for its product hydrobromide, was marketed under 16, 2010, requesting that these marketed under NDA 12–575; Cord NDA 11–265. All of the products were companies withdraw or affirm their Laboratories, Inc., 2555 W. Midway marketed as expectorants. outstanding hearing requests under this Blvd., Broomfield, CO 80020, for its IRS In response to the May 25, 1982, docket within 30 days. On December 7, product, a syrup containing codeine notice, timely hearing requests were 2010, Pfizer withdrew its hearing phosphate, triprolidine hydrochloride, filed by Bay Laboratories, 3654 West request. On December 10, 2010, Actavis pseudoephedrine hydrochloride, and Jarvis, Skokie, IL 60076, for its IRS withdrew its hearing request. guaifenesin; Lederle Laboratories, 401 products Promethazine Expectorant FDA was unable to find current N. Middletown Rd., Pearl River, NY with Codeine, Promethazine VC contact information for Bay Laboratories 10965, based on its distribution of Expectorant Plain, Promethazine VC and National Pharmaceuticals. If either Dimetane Expectorant; National Expectorant with Codeine, of these companies, or its successor-in- Pharmaceuticals, Inc., 7205 Windsor Promethazine Expectorant Plain, and interest, continues to have an interest in Blvd., Baltimore, MD 21207, for its Promethazine Pediatric Expectorant; pursuing its hearing requests under this products IRS to Dimetane Expectorant, Cord Laboratories, Inc., 2555 W. docket, the company (or its successor- Dimetane Expectorant DC, and Actifed- Midway Blvd., Broomfield, CO 80020, in-interest) must affirm its hearing C; and Purepac Pharmaceutical Co., 200 for two IRS products, the first a syrup request in writing by the date specified Elmora Ave., Elizabeth, NJ 07207, based containing codeine phosphate, in this notice. FDA will assume that on its distribution of an IRS product, promethazine hydrochloride, potassium hearing requests that are not affirmed Brompheniramine Maleate Expectorant. guaiacolsulfonate, citric acid, within that time frame are no longer On April 3, 1984, A.H. Robins, the anhydrous, sodium citrate, hydrous, and being pursued, and will deem them holder of the NDA for Dimetane ipecac fluidextract and the second a withdrawn. Expectorant and Dimetane Expectorant- syrup containing codeine phosphate, DC, withdrew its hearing request after promethazine hydrochloride, 2. Dimetane Expectorant, Dimetane approval of reformulated versions of its phenylephrine hydrochloride, Expectorant-DC, and Actifed-C products. Accordingly, on August 24, potassium guaiacolsulfonate, citric acid, Expectorant; Docket 81N–0396 (DESI 1984 (49 FR 33726), FDA announced anhydrous, sodium citrate, hydrous, and 6514) that it was withdrawing approval of ipecac fluidextract; Lederle In a notice published in the Federal those portions of NDA 11–694 Laboratories, 401 N Middletown Rd., Register on May 25, 1982 (47 FR 22609), pertaining to the old formulations of the Pearl River, NY 10965, for its products FDA revoked the temporary exemption Dimetane Expectorant products, IRS to the Phenergan products that permitted the drug products effective September 24, 1984. considered under this docket except for described below, and those products On September 14, 1984, FDA the pediatric formulation; National IRS to these products, to remain on the announced that it was withdrawing Pharmaceuticals, Inc., 7205 Windsor market beyond the time limit approval of those portions of NDA 12– Blvd., Baltimore, MD 21207, for its established for DESI. The notice also 575 pertaining to the old formulation of products IRS to all five Phenergan reclassified the products to lacking Actifed-C Expectorant (49 FR 36169), products considered under this docket; substantial evidence of effectiveness, effective October 15, 1984, after the Purepac Pharmaceutical Co., 200 Elmora and offered an opportunity for a hearing NDA holder, Burroughs Wellcome,

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES 1178 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices

obtained approval for a reformulated P.O. Box 9627, Kansas City, MO 64134, Spansules was reformulated to be a version of the product and withdrew its for its product marketed under NDA 9– controlled-release product containing 12 hearing request. On October 25, 1984, 319; and National Pharmaceuticals, Inc., mg chlorpheniramine maleate and 75 Cord also withdrew its hearing request 7205 Windsor Blvd., Baltimore, MD mg phenylpropanolamine. relating to this docket, based on 21207, for its products IRS to Ambenyl In response to the August 17, 1982, discontinuation of the product that was Expectorant. notice, timely hearing requests were the subject of the hearing request. On May 24, 1983 (48 FR 23311), FDA filed by B.F. Ascher & Co., 15501 West FDA sent letters to Pfizer, Inc., 235 announced that it was withdrawing 109th St., Lenexa, KS 66219, for its IRS East 42nd St., New York, NY 10017, approval of NDA 5–914 as it pertains to product Drize Slow-Release Capsules; successor to Lederle Laboratories, and to Pyribenzamine and Ephedrine Tablets, Cord Laboratories, Inc., 2555 West Actavis, 60 Columbia Rd., Building B, effective June 23, 1983, because no Midway Blvd., Broomfield, CO 80020, Morristown, NJ 07960, successor to hearing was requested for the product for its IRS product Profenade #2 S.R. Purepac Pharmaceuticals, on November by the NDA holder. On February 27, Capsules; Glaxo, Inc 1011 North 16, 2010, requesting that these 1984, Marion Laboratories, the NDA Arendell Ave, PO Box 1217, Zebulon, companies withdraw or affirm their holder for Ambenyl Expectorant, NC 27597, for its IRS product Histabid outstanding hearing requests under this withdrew its hearing request after a Duracaps; SmithKline & French docket within 30 days. On December 7, reformulated version of its product was Laboratories, 1500 Spring Garden St., 2010, Pfizer withdrew its hearing approved. Accordingly, on August 24, P.O. Box 7929, Philadelphia, PA 19101, request. On December 10, 2010, Actavis 1984 (49 FR 33726), FDA announced it for its product marketed under NDA 12– withdrew its hearing request. was withdrawing approval of those 152; and Zenith Laboratories, Inc., 140 FDA was unable to find current portions of NDA 9–319 pertaining to the LeGrand Ave., Northvale, NJ 07647, for contact information for Bay Laboratories old formulation of Ambenyl its IRS product, a sustained release and National Pharmaceuticals. If either Expectorant, effective September 24, product containing chlorpheniramine of these companies, or its successor-in- 1984. On January 16, 1985, Bay and phenylpropanolamine. Two late interest, continues to have an interest in Laboratories withdrew its hearing hearing requests were filed by Knoll pursuing its hearing request under this request relating to this docket. Pharmaceutical Co. (formerly Boots docket, the company (or its successor- FDA was unable to find current Pharmaceuticals, Inc.), 300 Tri-State in-interest) must affirm its hearing contact information for National International Center, suite 200, request in writing by the date specified Pharmaceuticals. If this company, or its Lincolnshire, IL 60069, for its IRS in this notice. FDA will assume that successor-in-interest, continues to have product Ru-Tuss Tablets, and Pioneer hearing requests that are not affirmed an interest in pursuing its hearing Pharmaceuticals, Inc., 209 40th St., within that time frame are no longer request under this docket, the company Irvington, NJ 07111, for its IRS product, being pursued, and will deem them (or its successor-in-interest) must affirm characterized by the company as a withdrawn. its hearing request in writing by the date generic version of Ornade Spansules. A specified in this notice. FDA will 3. Ambenyl Expectorant and assume that if this hearing request is not late hearing request was also filed by Pyribenzamine and Ephedrine Tablets; affirmed within that time frame, it is no Sidmak Laboratories, Inc., 17 West St., Docket 82N–0095 (DESI 6514, 11935) longer being pursued, and will deem it P.O. Box 371, East Hanover, NJ 07936, In a notice published in the Federal withdrawn. for two IRS products, one containing Register on May 25, 1982 (47 FR 22604), chlorpheniramine maleate 12 mg and FDA revoked the temporary exemption 4. Ornade Spansules; Docket 82N–0096 phenylpropanolamine, and the other that permitted the drug products (DESI 12152) containing chlorpheniramine maleate 8 described below, and those products In a notice published in the Federal mg and phenylpropanolamine. IRS to these product, to remain on the Register on August 17, 1982 (47 FR On December 12, 1984 (49 FR 48387), market beyond the time limit 35870), FDA revoked the temporary FDA announced that it was established for DESI. The notice also exemption that permitted the drug withdrawing approval of those portions reclassified the products to lacking product described below, and those of NDA 12–152 covering the old, three- substantial evidence of effectiveness, products IRS to this product, to remain ingredient formulation for Ornade and offered an opportunity for a hearing on the market beyond the time limit Spansules, effective January 11, 1985, on a proposal to withdraw approval of established for DESI. In the notice, FDA noting that no party submitted a hearing the NDAs for the products. also announced the conditions for request regarding the three-ingredient Ambenyl Expectorant, containing marketing these products, as formulation. On January 15, 1986, codeine sulfate, reformulated, for the indication for SmithKline, the NDA holder for Ornade bromodiphenhydramine hydrochloride, which they were regarded as effective, Spansules, withdrew its hearing request diphenhydramine hydrochloride, and offered an opportunity for a hearing after receiving FDA approval for its ammonium chloride, potassium concerning a proposal to withdraw supplemental NDAs covering the guaiacolsulfonate, and menthol, was approval of the NDA with respect to the reformulated product. Knoll marketed under NDA 9–319. old formulation and the indications Pharmaceutical withdrew its hearing Pyribenzamine and Ephedrine Tablets, reclassified to lacking substantial request relating to this docket on containing tripelennamine evidence of effectiveness. September 14, 1995. hydrochloride and 12 mg ephedrine Ornade Spansules, as formulated On October 21, 2009, B.F. Ascher & sulfate, were marketed under NDA 5– early in the DESI review process, was a Co. withdrew its hearing request 914. three-ingredient product containing 8 relating to this docket. On the same In response to the May 25, 1982, mg of chlorpheniramine maleate, 50 mg date, Sandoz, Inc., 2555 West Midway notice, hearing requests were filed by of phenylpropanolamine hydrochloride, Blvd., Broomfield, CO 80020, the Bay Laboratories, 3654 West Jarvis, and 2.5 mg of isopropamide, and was successor-in-interest to Cord Skokie, IL 60076, for Ambay marketed under NDA 12–152. Prior to Laboratories, Inc., withdrew its hearing Expectorant, its product IRS to Ambenyl the publication of the August 17, 1982, request. On February 15, 2010, Sidmak Expectorant; Marion Laboratories, Inc., Federal Register notice, Ornade Laboratories’ successor-in-interest, Teva

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1179

Pharmaceuticals, withdrew its hearing reclassified to lacking substantial for its products IRS to Dimetapp request. evidence of effectiveness. Extentabs and Dimetapp Elixir; Lemmon On November 9, 2009, Glaxo’s Dimetapp Extentabs, as formulated Co., 850 Cathill Rd., Sellersville, PA successor, GlaxoSmithKline, indicated during the period of the DESI review, 18960, for Phenatapp, its product IRS to it transferred its interest in Histabid was a controlled-release product Dimetapp Extentabs; LuChem Duracaps, the subject of its hearing containing 12 mg brompheniramine Pharmaceuticals, Inc., P.O. Box 6038, request, to Medeva Pharmaceuticals maleate, 15 mg phenylephrine 8910 Linwood Ave., Shreveport, LA sometime between 1984 and 1990, and hydrochloride, and 15 mg 71136, for its IRS products Ban-Tuss GlaxoSmithKline indicated to the law phenylpropanolamine hydrochloride, HC, Ban-Tuss C Expectorant, Tuss-Delay firm that had filed the hearing request and marketed under NDA 12–436. At Tablets, Ban-Tuss Plain, Klerist-D on behalf of Glaxo that it had no interest the time of the publication of the Tablets, Respergen, Am-Tuss Liquid, in pursuing the hearing request. The law December 23, 1983, Federal Register Novadyne DH, Novadyne Expectorant, firm was also able to contact UCB, the notice, the manufacturer had submitted Dexophed Tablets, Chem-Tuss-SR, successor to the Celltech Chiroscience, a supplemental application proposing to Chem-Tuss Elixir, Chem-Tuss DM, which had previously acquired Medeva reformulate the product to contain 12 Chem-Tuss DME, and Chem-Tuss N; Pharmaceuticals. UCB also indicated to mg brompheniramine maleate and 75 Mayrand Inc., 4 Dundas Circle, P.O. Box the law firm that had filed the hearing mg phenylpropanolamine 8860, Greensboro, NC 27419, for its request that it had no interest in hydrochloride in a controlled-release products IRS to Dimetapp Extentabs and pursuing the hearing request filed by form. Dimetapp Elixir was originally Dimetapp Elixir; National Glaxo for Histabid Duracaps. As the formulated to contain 4 mg Pharmaceutical Manufacturing Co., agency has not heard from UCB brompheniramine maleate, 5 mg 7205 Windsor Blvd., Baltimore, MD formally, the agency is providing the phenylephrine hydrochloride, and 5 mg 21207, for its product IRS to Dimetapp company an opportunity to affirm its phenylpropanolamine hydrochloride Elixir; Pharmaceutical Basics, Inc., 301 hearing request in writing by the date per 5 milliliters (mL), and was marketed S. Cherokee, Denver, CO 80223, for its specified in this notice. FDA will under NDA 13–087. At the time of the IRS product Basamine S.R. Tablets; assume that if this hearing request is not publication of the December 23, 1983, Pioneer Pharmaceuticals, Inc., 209 40th affirmed within that time frame the Federal Register notice, the St., Irvington, NJ 07111, for Pioten request is no longer being pursued, and manufacturer had submitted a Tablets, its product IRS to Dimetapp will deem it withdrawn. supplemental application proposing to Extentabs; Quantum Pharmics, Ltd., 26 reformulate the product to contain 4 mg Edison St., Amityville, NY 11701, for its FDA sent a letter to Zenith brompheniramine maleate and 25 mg IRS product, Brom-Tapp; Superpharm Laboratories on November 16, 2010 phenylpropanolamine hydrochloride Corp., 155 Oval Dr., Central Islip, NY requesting that the company withdraw per 5 mL. The supplements to NDA 12– 11722, for its product IRS to Dimetapp or affirm its outstanding hearing 436 and NDA 13–087 were subsequently Extentab Tablets; United States Trading requests under this docket within 30 approved by FDA on April 20, 1984, Corp., 10718 McCune Ave., Los days. As of December 13, 2010, Zenith and March 29, 1984, respectively. Angeles, CA 90034, for its products IRS Laboratories had not responded to FDA. In response to the December 23, 1983, to Dimetapp Extentabs; and Upsher- FDA was unable to find current notice, timely hearing requests were Smith Laboratories, Inc., 14905 23rd contact information for Pioneer filed by A.H. Robins, 1407 Cummings Ave. North, Minneapolis, MN 55441, for Pharmaceuticals, Inc. If this company, Dr., Richmond, VA 23220, for its unspecified products. A late hearing or its successor-in-interest, continues to products marketed under NDA 12–436 request was filed by Sidmak have an interest in pursuing its hearing and NDA 13–087; American Laboratories, Inc., 17 West St., P.O. Box request under this docket, the company Therapeutics, Inc., 75 Carlough Rd., 371, East Hanover, NJ 07936, for its (or its successor-in-interest) must affirm Bohemia, NY 11716, for its product IRS products IRS to Dimetapp Extentabs. its hearing request in writing by the date to Dimetapp Extentab Tablets; Amide On June 11, 1985, A.H. Robins, the specified in this notice. FDA will Pharmaceutical, Inc., 101 East Main St., NDA holder for Dimetapp Extentabs and assume that if this hearing request is not Little Falls, NJ 07424, for its IRS product Dimetapp Elixir, withdrew its hearing affirmed within that time frame the Ami-Tapp; Bay Laboratories, Inc., 3654 request relating to this docket, after request is no longer being pursued, and West Jarvis, Skokie, IL 60076, for reformulating its products to comply will deem it withdrawn Triphen Elixir, its product IRS to with the OTC monograph in part 341 5. Dimetapp Extentabs and Elixir; Dimetapp Elixir; Carnrick Laboratories, (21 CFR part 341), ‘‘Cold, Cough, Docket 83N–0095 (DESI 11935) Inc., 65 Horse Hill Rd., Cedar Knolls, NJ Allergy, Bronchodilator, and 07927, for Nolamine Timed Release Antihistamine Drug Products for Over- In a notice published in the Federal Tablets, its product IRS to Dimetapp the-Counter Human Use.’’ Accordingly, Register on December 23, 1983 (48 FR Extentabs; Copley Pharmaceutical, Inc., on July 19, 1985 (50 FR 29484), FDA 56854), FDA revoked the temporary 398 West Second St., P.O. Box 107, announced that it was withdrawing exemption that permitted the drug Boston, MA 02127, for its products IRS approval of those portions of NDAs 12– products described below, and those to Dimetapp Extentabs; Cord 436 and 13–087 pertaining to the old products IRS to these products, to Laboratories, Inc., 2555 West Midway formulations of the Dimetapp products, remain on the market beyond the time Blvd., Broomfield, CO 80020, for effective August 19, 1985. limit established for DESI. In the notice, Cordamine-PA Tablets, its product IRS On August 23, 1984, Lemmon Co. FDA also announced the conditions for to Dimetapp Extentabs; D.M. Graham withdrew its hearing request relating to marketing these products, as Laboratories, Inc., Hobart, NY 13788, for this docket. Sandoz, Inc., 2555 West reformulated, for the indication for unspecified IRS products; Forest Midway Blvd., Broomfield, CO 80020, which they were regarded as effective, Laboratories, Inc., 909 Third Ave., New the successor-in-interest to Cord and offered an opportunity for a hearing York, NY 10022, for its IRS products Laboratories, Inc., withdrew its hearing concerning a proposal to withdraw Brocon C.R. Tablets and Chewable request on October 21, 2009. Forest approval of the NDAs for the old Brocon Tablets; Halsey Drug Co. Inc., Laboratories, Inc., withdrew its hearing formulations and for the indications 1827 Pacific St., Brooklyn, NY 11233, request on October 22, 2009. The

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES 1180 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices

hearing request filed by D.M. Graham discontinued. The letter should be sent ACTION: Notice of availability; request Laboratories, Inc., was withdrawn on to Sakineh Walther (see ADDRESSES). for comments. December 10, 2009. D.M. Graham Firms should also update the listing Laboratories was previously acquired by of their products under section 510(j) of SUMMARY: As part of the third phase of Mallinckrodt, Inc., which is now part of the FD&C Act to reflect discontinuation the Transparency Initiative, the Food Covidien, 172 Railroad Ave., Hobart, NY of unapproved products. FDA plans to and Drug Administration (FDA) is 13788. Teva Pharmaceuticals, the rely on its existing records, including announcing the availability of a report successor-in-interest to Sidmak drug listing records or other available entitled ‘‘FDA Transparency Initiative: Laboratories, withdrew its hearing information, when it targets violations Improving Transparency to Regulated request on February 15, 2010. Acura for enforcement action. Firms should be Industry.’’ The report includes 19 action Pharmaceutical Co., 616 N. North Court, aware that, after the effective date of this items and 5 draft proposals to improve Palantine, IL 60067, successor to Halsey notice, FDA intends to take enforcement transparency to regulated industry. FDA Drug Co., withdrew its hearing request action without further notice against is seeking public comment on the on November 23, 2010. any firm that manufactures or ships in content of the draft proposals, as well as FDA sent a letter to Merz interstate commerce any unapproved on which draft proposals should be Pharmaceuticals, LLC, P.O. Box 18806, product covered by this notice that is given priority. Greensboro, NC 27419, successor to not the subject of an ongoing DESI DATES: Submit electronic or written Mayrand, Inc., Pharmaceuticals, on proceeding. comments by March 8, 2011. November 16, 2010, requesting that this ADDRESSES: Submit electronic IV. Reformulated Products company withdraw or affirm its comments to http:// outstanding hearing request under this Some of the active ingredients found www.regulations.gov. Submit written docket within 30 days. As of December in drug products covered by this notice comments to the Division of Dockets 13, 2010, the company had not are included in the OTC monograph in Management (HFA–305), Food and Drug responded to FDA. part 341 (21 CFR part 341), ‘‘Cold, Administration, 5630 Fishers Lane, rm. FDA was unable to find current Cough, Allergy, Bronchodilator, and 1061, Rockville, MD 20852. All contact information for American Antihistamine Drug Products for Over- comments should be identified with the Therapeutics, Amide Pharmaceutical, the-Counter Human Use.’’ OTC products docket number found in brackets at the Inc., Bay Laboratories, Inc., National that comply with this monograph may heading of this document. Pharmaceutical Manufacturing Co., be marketed without approval. FOR FURTHER INFORMATION CONTACT: Ann Pharmaceutical Basics, Inc., However, FDA cautions firms against Witt, Office of Policy, Planning, and Superpharm Corp., and United States reformulating products into OTC Budget, Food and Drug Administration, Trading Corp. FDA did not receive any products or different unapproved new 10903 New Hampshire Ave., Bldg 32, response to its attempt to contact drugs that are marketed under the same rm. 4226, Silver Spring, MD 20993, Carnrick Laboratories, a subsidiary of name or substantially the same name 301–796–7463, FAX: 301–847–8616, e- Elan Corporation; Copley (including a new name that contains the mail: [email protected]. Pharmaceutical, Inc.; LuChem old name). Reformulated products SUPPLEMENTARY INFORMATION: Pharmaceuticals, Inc.; Pioneer marketed under a name previously Pharmaceuticals, Inc.; Quantum identified with a different active I. Background on the FDA Pharmics, Ltd.; or Upsher-Smith ingredient or combination of active Transparency Initiative Laboratories, Inc. If any of these ingredients have the potential to In January 2009, President Obama companies, or their successors-in- confuse health care practitioners and issued a memorandum on Transparency interest, continue to have an interest in harm patients. and Open Government calling for an pursuing their hearing requests under This notice is issued under the ‘‘unprecedented level of openness in this docket, the companies (or their Federal Food, Drug, and Cosmetic Act Government’’ and directing the Director successors-in-interest) must affirm their (sections 502 and 505 (21 U.S.C. 352 of the Office of Management and Budget hearing requests in writing by the date and 355), and under authority delegated (OMB) to issue an Open Government specified in this notice. FDA will to the Assistant Commissioner for Directive instructing executive assume that hearing requests that are Policy under section 1410.21 of the FDA departments and agencies to take not affirmed within that time frame are Staff Manual Guide. specific actions to implement the no longer being pursued, and will deem Dated: January 3, 2011. principles of transparent, collaborative, them withdrawn. Leslie Kux, and participatory government. The Open Government Directive was issued III. Discontinued Products Acting Assistant Commissioner for Policy. December 8, 2009. Under the leadership Some firms may have previously [FR Doc. 2011–104 Filed 1–6–11; 8:45 am] of Secretary of Health and Human discontinued the manufacturing or BILLING CODE 4160–01–P Services, Kathleen Sebelius, the U.S. distribution of products covered by this Department of Health and Human notice without removing them from the DEPARTMENT OF HEALTH AND Services has also prioritized listing of their products under section HUMAN SERVICES transparency and openness. In June 510(j) of the FD&C Act. Other firms may 2009, the Commissioner of Food and discontinue manufacturing or marketing Food and Drug Administration Drugs (the Commissioner), Dr. Margaret listed products in response to this Hamburg, launched FDA’s notice. Firms that wish to notify the Transparency Initiative to implement [Docket No. FDA–2009–N–0247] agency of product discontinuation these efforts at FDA. should send a letter, signed by the firm’s FDA Transparency Initiative: Improving The initiative is overseen by a Task chief executive officer, fully identifying Transparency to Regulated Industry Force representing key leaders of FDA. the discontinued product(s), including The internal Task Force is chaired by NDC number(s), and stating that the AGENCY: Food and Drug Administration, the Principal Deputy Commissioner of product(s) has (have) been HHS. FDA and includes five of the Agency’s

VerDate Mar<15>2010 15:30 Jan 06, 2011 Jkt 223001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 jdjones on DSK8KYBLC1PROD with NOTICES