1516 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices

(HCl), dopamine HCl, edetate calcium DEPARTMENT OF HEALTH AND which they are seeking approval disodium, folic acid, glycopyrrolate, HUMAN SERVICES contains the same active ingredient in hydroxyzine HCl, ketorolac the same strength and dosage form as tromethamine, labetalol HCl, mannitol, Food and Drug Administration the ‘‘listed drug,’’ which is a version of metoclopramide HCl, moxifloxacin HCl, [Docket No. FDA–2020–N–2300] the drug that was previously approved. nalbuphine HCl, polidocanol, potassium ANDA applicants do not have to repeat acetate, procainamide HCl, sodium Determination That ARALEN the extensive clinical testing otherwise nitroprusside, sodium thiosulfate, and (Chloroquine Phosphate) Oral Tablets, necessary to gain approval of a new verapamil HCl. Interested persons were 500 Milligrams, and Other Drug drug application (NDA). originally given until September 29, Products Were Not Withdrawn From The 1984 amendments include what 2020, to comment on FDA’s proposals. Sale for Reasons of Safety or is now section 505(j)(7) of the Federal Effectiveness Food, Drug, and Cosmetic Act (21 U.S.C. During the comment period for the 355(j)(7)), which requires FDA to July 31, 2020, notice, FDA received a AGENCY: Food and Drug Administration, publish a list of all approved drugs. request to allow interested persons HHS. FDA publishes this list as part of the additional time to comment. The ACTION: Notice. ‘‘Approved Drug Products With requester asserted that the time period Therapeutic Equivalence Evaluations,’’ SUMMARY: The Food and Drug of 60 days was insufficient to respond which is known generally as the Administration (FDA or Agency) has fully to FDA’s specific requests for ‘‘Orange Book.’’ Under FDA regulations, determined that the drug products listed comments and noted the commenter’s a drug is removed from the list if the in this document were not withdrawn obligations to respond to the exigencies Agency withdraws or suspends from sale for reasons of safety or of COVID–19 pandemic. approval of the drug’s NDA or ANDA effectiveness. This determination means for reasons of safety or effectiveness, or FDA has considered the request and that FDA will not begin procedures to if FDA determines that the listed drug other relevant factors, and accordingly withdraw approval of abbreviated new was withdrawn from sale for reasons of is reopening the comment period for the drug applications (ANDAs) that refer to safety or effectiveness (21 CFR 314.162). July 31, 2020, notice for 30 days, until these drug products, and it will allow Under § 314.161(a) (21 CFR February 8, 2021. The Agency believes FDA to continue to approve ANDAs that 314.161(a)), the Agency must determine that an additional 30 days will allow refer to the products as long as they whether a listed drug was withdrawn meet relevant legal and regulatory adequate time for interested persons to from sale for reasons of safety or requirements. submit comments. effectiveness: (1) Before an ANDA that Dated: January 4, 2021. FOR FURTHER INFORMATION CONTACT: refers to that listed drug may be Lauren K. Roth, Stacy Kane, Center for Drug Evaluation approved, (2) whenever a listed drug is and Research, Food and Drug Acting Principal Associate Commissioner for voluntarily withdrawn from sale and Administration, 10903 New Hampshire Policy. ANDAs that refer to the listed drug have Ave., Bldg. 51, Rm. 6236, Silver Spring, been approved, and (3) when a person [FR Doc. 2021–00123 Filed 1–7–21; 8:45 am] MD 20993–0002, 301–796–8363, petitions for such a determination under BILLING CODE 4164–01–P [email protected]. 21 CFR 10.25(a) and 10.30. Section SUPPLEMENTARY INFORMATION: In 1984, 314.161(d) provides that if FDA Congress enacted the Drug Price determines that a listed drug was Competition and Patent Term withdrawn from sale for safety or Restoration Act of 1984 (Pub. L. 98–417) effectiveness reasons, the Agency will (the 1984 amendments), which initiate proceedings that could result in authorized the approval of duplicate the withdrawal of approval of the versions of drug products approved ANDAs that refer to the listed drug. under an ANDA procedure. ANDA FDA has become aware that the drug applicants must, with certain products listed in the table are no longer exceptions, show that the drug for being marketed.

Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant

NDA 006002 ARALEN ...... Chloroquine Phos- 500 milligrams (mg) ...... Tablet; Oral ...... Sanofi-Aventis U.S. phate. LLC. NDA 006134 DOLOPHINE HY- Methadone Hydro- 5 mg; 10 mg ...... Tablet; Oral ...... Hikma Pharma- DROCHLORIDE. chloride. ceuticals PLC. NDA 007409 BENTYL ...... Dicyclomine Hydro- 10 mg ...... Capsule; Oral ...... Allergan Pharma- chloride. ceuticals. Dicyclomine Hydro- 20 mg ...... Tablet; Oral. chloride. NDA 008085 Methotrexate Sodium Methotrexate Sodium Equivalent to (EQ) 2.5 mg Base Tablet; Oral ...... DAVA Pharma- ceuticals, Inc. NDA 008678 Isoniazid ...... Isoniazid ...... 100 mg; 300 mg ...... Tablet; Oral ...... Sandoz. NDA 012945 DIAMOX ...... Acetazolamide ...... 500 mg ...... Extended-Release Teva Branded Phar- Capsule; Oral. maceutical Prod- ucts. NDA 014103 ONCOVIN ...... Vincristine Sulfate ..... 1 mg/milliliter (mL); 1 mg/Vial; 5 Injectable; Injection ... Eli Lilly and Co. mg/Vial. NDA 016792 SURMONTIL ...... Trimipramine Maleate EQ 25 mg/Base; EQ 50 mg/ Capsule; Oral ...... Teva Women’s Base; EQ 100 mg/Base. Health, Inc.

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Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant

NDA 016801 XYLOCAINE PRE- Lidocaine Hydro- 1%; 2%; 4%; 10%; 20% ...... Injectable; Injection ... Fresenius Kabi USA, SERVATIVE FREE. chloride. LLC. NDA 018238 MICRO–K ...... Potassium Chloride.. 8 milliequivalents (mEq); 10 Extended-Release Nesher Pharma- mEq. Capsule; Oral. ceuticals LLC. NDA 019568 DERMATOP ...... Prednicarbate ...... 0.10% ...... Ointment; Topical ..... Valeant Pharma- ceuticals. NDA 020192 LAMISIL ...... Terbinafine Hydro- 1% ...... Cream; Topical ...... Novartis. chloride. NDA 020482 PRECOSE ...... Acarbose ...... 25 mg; 50 mg; 100 mg ...... Tablet; Oral ...... Bayer Healthcare. NDA 020591 TARKA ...... Trandolapril; 1 mg; 240 mg ...... Extended-Release AbbVie Inc. Verapamil Hydro- Tablet; Oral. chloride. NDA 020635 LEVAQUIN ...... Levofloxacin ...... EQ 500 mg/20 mL; EQ 750 mg/ Injectable; Injection ... Janssen Pharma- 30 mL. ceuticals, Inc. NDA 020823 EXELON ...... Rivastigmine Tartrate EQ 1.5 mg Base; EQ 3 mg Capsule; Oral ...... Novartis. Base; EQ 4.5 mg Base; EQ 6 mg Base. NDA 020920 NATRECOR ...... Nesiritide ...... 1.5 mg/Vial ...... For Solution; Intra- Scios Inc. venous. NDA 021549 EMEND ...... Aprepitant ...... 40 mg ...... Capsule; Oral ...... Merck. NDA 021590 FAZACLO ODT ...... Clozapine ...... 12.5 mg; 25 mg; 100 mg; 150 Orally Disintegrating Jazz Pharmaceuticals mg; and 200 mg. Tablet; Oral. PLC. NDA 202535 PREPOPIK ...... Citric Acid, Magne- 12 grams (g)/Packet; 3.5 g/ For Solution; Oral ..... Ferring Pharma- sium Oxide, and Packet; 10 mg/Packet. ceuticals Inc. Sodium Picosulfate.

FDA has reviewed its records and, DEPARTMENT OF HEALTH AND the meeting will be held, visit the under § 314.161, has determined that HUMAN SERVICES NACNHSC website 30 business days the drug products listed were not before the date of the meeting, where withdrawn from sale for reasons of Health Resources and Services instructions for joining meetings either safety or effectiveness. Accordingly, the Administration in-person or remotely will also be Agency will continue to list the drug posted. In-person NACNHSC meetings Meeting of the National Advisory products in the ‘‘Discontinued Drug will be held at 5600 Fishers Lane, Committee on the National Health Rockville, Maryland 20857. For meeting Product List’’ section of the Orange Service Corps Book. The ‘‘Discontinued Drug Product information updates, go to the List’’ identifies, among other items, drug AGENCY: Health Resources and Services NACNHSC website meeting page at products that have been discontinued Administration (HRSA), Department of https://nhsc.hrsa.gov/nac/ from marketing for reasons other than Health and Human Services (HHS). meetings.html. safety or effectiveness. ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Approved ANDAs that refer to the Diane Fabiyi-King (DFO), Division of SUMMARY: In accordance with the National Health Service Corps, Bureau NDAs and ANDAs listed are unaffected Federal Advisory Committee Act, this of Health Workforce, HRSA, 5600 by the discontinued marketing of the notice announces that the National Fishers Lane, Rockville, Maryland products subject to those NDAs and Advisory Committee on the National 20857; 301–443–3609; or ANDAs. Additional ANDAs that refer to Health Service Corps (NACNHSC) will [email protected]. these products may also be approved by hold public meetings for the 2021 SUPPLEMENTARY INFORMATION: the Agency if they comply with relevant calendar year (CY). Information about NACNHSC provides advice and legal and regulatory requirements. If NACNHSC, agendas, and materials for recommendations to the Secretary of FDA determines that labeling for these these meetings can be found on the HHS (Secretary) on policy, program drug products should be revised to meet NACNHSC website at https:// development, and other matters of current standards, the Agency will nhsc.hrsa.gov/about/national-advisory- significance concerning the activities advise ANDA applicants to submit such council-nhsc/index.html. under Subpart II, Part D of Title III of labeling. DATES: NACNHSC meetings will be held the Public Health Service Act (42 U.S.C. Dated: January 4, 2021. on 254d–254k). NACNHSC designates areas • March 16, 2021, 9:00 a.m.–5:00 p.m. Lauren K. Roth, of the United States with health Eastern Time (ET) and March 17, 2021, professional shortages and assigns Acting Principal Associate Commissioner for 9:00 a.m.–2:00 p.m. ET; Policy. National Health Service Corps clinicians • June 22, 2021, 9:00 a.m.–5:00 p.m. to improve the delivery of health [FR Doc. 2021–00118 Filed 1–7–21; 8:45 am] ET and June 23, 2021, 9:00 a.m.–2:00 services in health professional shortage BILLING CODE 4164–01–P p.m. ET; areas. Since priorities dictate meeting • November 9, 2021, 9:00 a.m.–5: 00 times and agenda items, be advised that p.m. ET and November 10, 2021, 9:00 start times, end times, and agenda items a.m.–2:00 p.m. ET. are subject to change. For CY 2021 ADDRESSES: Meetings may be held in- meetings, agenda items may include, person, by teleconference, and/or Adobe but are not limited to, the identification Connect webinar. For updates on how of NACNHSC priorities for future

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