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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2020-N-2300]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
 FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
                        *Stacy.Kane@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
ApplicantNDA 006002
ARALEN
Chloroquine Phosphate
500 milligrams (mg)
Tablet; Oral
Sanofi-Aventis U.S. LLC.NDA 006134
DOLOPHINE HYDROCHLORIDE
Methadone Hydrochloride
5 mg; 10 mg
Tablet; Oral
Hikma Pharmaceuticals PLC.NDA 007409
BENTYL
Dicyclomine Hydrochloride
10 mg
Capsule; Oral
Allergan Pharmaceuticals.Dicyclomine Hydrochloride
20 mg
Tablet; OralNDA 008085
Methotrexate Sodium
Methotrexate Sodium
Equivalent to (EQ) 2.5 mg Base
Tablet; Oral
DAVA Pharmaceuticals, Inc.NDA 008678
Isoniazid
Isoniazid
100 mg; 300 mg
Tablet; Oral
Sandoz.NDA 012945
DIAMOX
Acetazolamide
500 mg
Extended-Release Capsule; Oral
Teva Branded Pharmaceutical Products.NDA 014103
ONCOVIN
Vincristine Sulfate
1 mg/milliliter (mL); 1 mg/Vial; 5 mg/Vial
Injectable; Injection
Eli Lilly and Co.NDA 016792
SURMONTIL
Trimipramine Maleate
EQ 25 mg/Base; EQ 50 mg/Base; EQ 100 mg/Base
Capsule; Oral
Teva Women's Health, Inc.( print page 1517)NDA 016801
XYLOCAINE PRESERVATIVE FREE
Lidocaine Hydrochloride
1%; 2%; 4%; 10%; 20%
Injectable; Injection
Fresenius Kabi USA, LLC.NDA 018238
MICRO-K
Potassium Chloride
8 milliequivalents (mEq); 10 mEq
Extended-Release Capsule; Oral
Nesher Pharmaceuticals LLC.NDA 019568
DERMATOP
Prednicarbate
0.10%
Ointment; Topical
Valeant Pharmaceuticals.NDA 020192
LAMISIL
Terbinafine Hydrochloride
1%
Cream; Topical
Novartis.NDA 020482
PRECOSE
Acarbose
25 mg; 50 mg; 100 mg
Tablet; Oral
Bayer Healthcare.NDA 020591
TARKA
Trandolapril; Verapamil Hydrochloride
1 mg; 240 mg
Extended-Release Tablet; Oral
AbbVie Inc.NDA 020635
LEVAQUIN
Levofloxacin
EQ 500 mg/20 mL; EQ 750 mg/30 mL
Injectable; Injection
Janssen Pharmaceuticals, Inc.NDA 020823
EXELON
Rivastigmine Tartrate
EQ 1.5 mg Base; EQ 3 mg Base; EQ 4.5 mg Base; EQ 6 mg Base
Capsule; Oral
Novartis.NDA 020920
NATRECOR
Nesiritide
1.5 mg/Vial
For Solution; Intravenous
Scios Inc.NDA 021549
EMEND
Aprepitant
40 mg
Capsule; Oral
Merck.NDA 021590
FAZACLO ODT
Clozapine
12.5 mg; 25 mg; 100 mg; 150 mg; and 200 mg
Orally Disintegrating Tablet; Oral
Jazz Pharmaceuticals PLC.NDA 202535
PREPOPIK
Citric Acid, Magnesium Oxide, and Sodium Picosulfate
12 grams (g)/Packet; 3.5 g/Packet; 10 mg/Packet
For Solution; Oral
Ferring Pharmaceuticals Inc.
 FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: January 4, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.


[FR Doc. 2021-00118 Filed 1-7-21; 8:45 am] BILLING CODE 4164-01-P