86 FR 5 pgs. 1516-1517 - Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 86Number: 5Pages: 1516 - 1517
Pages: 1516, 1517Docket number: [Docket No. FDA–2020–N–2300]
FR document: [FR Doc. 2021–00118 Filed 1–7–21; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2300]
Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.
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| Application No. | Drug name | Active ingredient(s) | Strength(s) | Dosage form/route | Applicant |
|---|---|---|---|---|---|
| NDA 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; Oral | |||
| NDA 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. |
| 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