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Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 / Notices 69631

The fabricated data were not included and Evaluation (HFP–20), Food and DEPARTMENT OF HEALTH AND in any publications. Drug Administration, 5600 Fishers HUMAN SERVICES Ms. Restrepo has accepted the ORI Lane, Rockville, MD 20857, 301–827– finding and has entered into a Voluntary 5207. Food and Drug Administration Exclusion Agreement with ORI in which she has voluntarily agreed, for the three SUPPLEMENTARY INFORMATION: In FR Doc. [Docket No. 78N±0280; DESI Nos. 740, 1543, and 7661] (3) year period beginning December 7, 98–31387 beginning on page 65000 in the Federal Register of Tuesday, 1998: for Postpartum Breast November 24, 1998, the following (1) To exclude herself from serving in Engorgement; Withdrawal of Approval any advisory capacity to the Public corrections are made: of the Labeled Indication for Health Service (PHS), including but not 1. On page 65000, in the first column, Postpartum Breast Engorgement in limited to service on any PHS advisory in the second paragraph of the -Containing Drug Products; committee, board, and/or peer review ‘‘ADDRESSES’’ section, in lines eight Final Order committee, or as a consultant; and and nine, ‘‘http://www.fda.gov/opacom/ AGENCY: (2) That any institution that submits 7modact’’ is corrected to read ‘‘http:// Food and Drug Administration, HHS. an application for PHS support for a www.fda.gov/opacom/7modact.html’’. research project on which her ACTION: Notice. participation is proposed or which uses 2. On page 65039, in the table, under her in any capacity on PHS supported the ‘‘Time frame’’ column, under the SUMMARY: The Food and Drug research, or that submits a report of subheading ‘‘Non-PDUFA’’, in line Administration (FDA) is withdrawing PHS-funded research in which she is three, the phrase ‘‘and PLA/BLA major approval of estrogen-containing drugs involved, must concurrently submit a supplements’’ is removed. insofar as they are indicated for use in plan for supervision of her duties to the 3. On page 65039, in the table, under postpartum breast engorgement. The funding agency for approval. The the ‘‘Overdue’’ column, in the 5th entry, basis for the action is that estrogens are supervisory plan must be designed to ‘‘(CBER)’’ is removed; in the same table, not shown to be safe for that use. ensure the scientific integrity of Ms. in the same column, in the 6th entry EFFECTIVE DATE: December 17, 1998. Restrepo’s research contribution. The ‘‘142’’ is added; in the 10th entry, ‘‘52’’ FOR FURTHER INFORMATION CONTACT: institution also must submit a copy of is added; and in the 11th entry, ‘‘6’’ is David T. Read, Center for Drug the supervisory plan to ORI. added. Evaluation and Research (HFD–7), Food FOR FURTHER INFORMATION CONTACT: and Drug Administration, 5600 Fishers Acting Director, Division of Research 4. On page 65039, in the third column Lane, Rockville, MD 20857, 301–594– Investigations, Office of Research following the table, in lines eight and 2041. nine, ‘‘http://www.fda.gov/oc/fdama/ Integrity, 5515 Security Lane, Suite 700, SUPPLEMENTARY INFORMATION: For many Rockville, MD 20852, (301) 443-5330. fdamapln/appenda’’ is corrected to read years, estrogen-containing drug Chris B. Pascal, ‘‘http://www.fda.gov/oc/fdama/ products were used to suppress Acting Director, Office of Research Integrity. fdamapln/appenda.htm’’. postpartum breast engorgement. By the [FR Doc. 98–33405 Filed 12–16–98; 8:45 am] 5. On page 65040, in the first column, 1970’s, however, the use of estrogens BILLING CODE 4160±17±P in lines 12 and 13, ‘‘http:// was shown to be associated with an www.fda.gov/oc/fdama/fdamapln/ increased risk of puerperal appendb’’ is corrected to read ‘‘http:// thromboembolism. Moreover, estrogen DEPARTMENT OF HEALTH AND www.fda.gov/oc/fdama/fdamapln/ dosages for the suppression of HUMAN SERVICES appendb.htm’’; on that same page, in the postpartum breast engorgement were second column, in lines 4 and 5, ‘‘http:/ higher than for other labeled Food and Drug Administration /www.fda.gov/oc/fdama/fdamapln/ indications. The risk of thromboembolism was first evaluated by [Docket No. 98N±0339] appendc’’ is corrected to read ‘‘http:// www.fda.gov/oc/fdama/fdamapln/ the FDA Obstetrics and Gynecology FDA Plan for Statutory Compliance; appendc.htm’’; and on that same page, Advisory Committee, now called the Correction in the same column, in lines 15 and 16, Advisory Committee for Reproductive Health Drugs (the Committee), on July ‘‘http://www.fda.gov/oc/fdama/ AGENCY: Food and Drug Administration, 15 and 16, 1976. At that time, the fdamapln/appendd’’ is corrected to HHS. Committee recommended that estrogen read‘‘http://www.fda.gov/oc/fdama/ ACTION: Notice; correction. drug products indicated for the fdamapln/appendd.htm’’. suppression of postpartum breast SUMMARY: The Food and Drug Dated: December 8, 1998. engorgement contain an insert stating Administration (FDA) is correcting a William K. Hubbard, that the risk of thromboembolism notice of availability that appeared in Associate Commissioner for Policy should be considered in conjunction the Federal Register of November 24, Coordination. with the risk-free alternative of the use 1998 (63 FR 65000). The notice [FR Doc. 98–33353 Filed 12–16–98; 8:45 am] of breast binding and mild analgesics. announced the availability of the ‘‘FDA On January 31, 1978, after additional Plan for Statutory Compliance’’ which BILLING CODE 4160±01±F risk evaluation, the Committee was published in compliance with the recommended that estrogen-containing Food and Drug Administration drug products’ indication for the Modernization Act of 1997. The suppression of postpartum breast document was published with minor engorgement be withdrawn. errors. This document corrects those In a notice of opportunity for hearing errors. (NOOH) published in the Federal FOR FURTHER INFORMATION CONTACT: Register of October 24, 1978 (43 FR Steven H. Chasin, Office of Planning 49564), the agency proposed to 69632 Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 / Notices withdraw approval of all new drug 15. NDA 9–402; Delestrogen Injection, for Drug Evaluation and Research (21 applications (NDA’s) for estrogen- Delestrogen 4X Injection, and CFR 5.82). containing drug products labeled for use Delestrogen 2X Injection containing Dated: November 30, 1998. in postpartum breast engorgement valerate; E. R. Squibb & Sons, Janet Woodcock, approved either before or after the Drug Inc. Director, Center for Drug Evaluation and Amendments of 1962 (Pub. L. 87–781). 16. NDA 9–545; Deladumone Research. The NOOH also applied to any Injection containing [FR Doc. 98–33455 Filed 12–16–98; 8:45 am] identical, similar, or related drug enanthate and ; E. R. product whether or not it was the Squibb & Sons, Inc. BILLING CODE 4160±01±F subject of an NDA. The NOOH listed the 17. NDA 10–597; Tace- following NDA’s: Capsules containing DEPARTMENT OF HEALTH AND 1. NDA 0–740; Di-Ovocylin Injection and ; Merrell- HUMAN SERVICES containing ; Ciba National Laboratories. Pharmaceutical Co., Division Ciba Giegy 18. NDA 11–444; Tace Capsules Food and Drug Administration Corp., 556 Morris Ave., Summit, NJ containing chlorotrianisene and Tace 07901. with Ergonovine Capsules containing [Docket No. 98E±0227] 2. NDA 4–039; Ect. chlorotrianisene and ergonovine Determination of Regulatory Review containing ; Eli Lilly & maleate; Merrell-National Laboratories. Period for Purposes of Patent Co., Box 618, Indianapolis, IN 46206. 19. NDA 16–235; Tace 72-Milligram Extension; Silicone AMO ARRAY 3. NDA 4–041; Stilbestrol Tablets and Capsule containing chlorotrianisene; Multifocal IOL Injection containing diethylstilbestrol; Merrell-National Laboratories. Eli Lilly & Co. 20. NDA 16–768; Estrovis Tablets AGENCY: Food and Drug Administration, 4. NDA 4–056; Stilbestrol Tablets, containing ; Warner Chilcott HHS. Injection, and Suppositories containing Laboratories, Division Warner Lambert ACTION: Notice. diethylstilbestrol; E. R. Squibb & Sons, Co., 201 Tabor Rd., Box W, Morris Inc., Box 4000, Princeton, NJ 08540. Plains, NJ 07950. SUMMARY: The Food and Drug 5. NDA 4–073; Stilbestrol Perles, In response to the NOOH, Merrell- Administration (FDA) has determined Injection and Suppositories containing the regulatory review period for Silicone National Laboratories, Parke-Davis, E. R.   diethylstilbestrol; The Upjohn Co., 7171 Squibb & Sons, Inc., Byk-Gulden, Inc., AMO ARRAY multifocal IOL and is Portage Rd., Kalamazoo, MI 49002. and the American College of publishing this notice of that 6. NDA 4–782; Premarin Tablets Obstetricians and Gynecologists (the determination as required by law. FDA containing ; Ayerst College) requested hearings, but the has made the determination because of Laboratories, Division of American firms voluntarily agreed to remove the the submission of an application to the Home Products Corp., 685 Third Ave., indication from their labeling. Since Commissioner of Patents and New York, NY 10017. then, the College and the firms, or their Trademarks, Department of Commerce, 7. NDA 4–823; Injection respective successors in interest, have for the extension of a patent which containing estrone; Abbott Laboratories, withdrawn their hearing requests. (The claims that medical device. 14th and Sheridan Rd., North Chicago, approvals of NDA 7–661, NDA 8–099, ADDRESSES: Written comments and IL 60064. and NDA 9–545 were withdrawn in a petitions should be directed to the 8. NDA 5–159; Diethylstilbestrol Federal Register notice of October 29, Dockets Management Branch (HFA– Dipropionate Tablets containing 1998 (63 FR 58053); the approval of 305), Food and Drug Administration, diethylstilbestrol dipropionate; Blueline NDA 10–597 was withdrawn in a 5630 Fishers Lane, rm. 1061, Rockville, Laboratories, Inc., 302 South Broadway, Federal Register notice of June 25, 1993 MD 20852. St. Louis, MO 63102. (58 FR 34466); the approval of NDA 16– FOR FURTHER INFORMATION CONTACT: 9. NDA 5–233; Diethylstilbestrol 768 was withdrawn in a Federal Brian J. Malkin, Office of Health Affairs Tablets containing diethylstilbestrol; Register notice of March 27, 1996 (61 (HFY–20), Food and Drug High Chemical Co., 1760 North Howard FR 13506).) Administration, 5600 Fishers Lane, St., Philadelphia, PA 19122. Therefore, for reasons stated in the Rockville, MD 20857, 301–827–6620. 10. NDA 5–292; Estinyl Tablets NOOH of October 24, 1978, as well as SUPPLEMENTARY INFORMATION: The Drug containing ethinyl estradiol; Schering the reasons discussed above, the Price Competition and Patent Term Corp., Galloping Hill Rd., Kenilworth, Director of the Center for Drug Restoration Act of 1984 (Pub. L. 98–417) NJ 07033. Evaluation and Research hereby and the Generic Animal Drug and Patent 11. NDA 7–661; AE Tablets and withdraws approval of any estrogen- Term Restoration Act (Pub. L. 100–670) Tylosterone Tablets containing containing drug product insofar as it is generally provide that a patent may be diethylstilbestrol and labeled for the suppression of extended for a period of up to 5 years methyltestosterone; Eli Lilly & Co. postpartum breast engorgement. (In the so long as the patented item (human 12. NDA 8–099; Tylosterone Injection Federal Register of January 17, 1995 (60 drug product, animal drug product, containing diethylstilbestrol and FR 3404), FDA withdrew approval of medical device, food additive, or color methyltestosterone; Eli Lilly & Co. bromocriptine mesylate for the additive) was subject to regulatory 13. NDA 8–102; Tace Tablets and indication of the prevention of review by FDA before the item was Capsules containing chlorotrianisene; physiological lactation, i.e., postpartum marketed. Under these acts, a product’s Merrell-National Laboratories, Division breast engorgement; today’s action regulatory review period forms the basis of Richardson-Merrell Inc., 110 East means, therefore, that no product is for determining the amount of extension Amity Rd., Cincinnati, OH 45215. currently approved for this indication.) an applicant may receive. 14. NDA 8–579; Vallestril Tablets This notice is issued under authority A regulatory review period consists of containing methallenestril; Searle delegated to the Commissioner of Food two periods of time: A testing phase and Laboratories, Division of G. D. Searle & and Drugs (21 CFR 5.10(a)(1)) and an approval phase. For medical devices, Co., Box 5100, Chicago, IL 60680. redelegated to the Director of the Center the testing phase begins with a clinical