Notices. Notice
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/register/2024/08/08/2024-17649A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2024-N-3531] Determination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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:
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product:
(1)has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and
(2)is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act 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 generally known 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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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. Table 1—Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 009165 DELATESTRYL Testosterone Enanthate 200 Milligrams (mg)/Milliliter
(mL)Injectable; Injection Endo Pharmaceuticals Inc. NDA 011145 DIURIL Chlorothiazide Sodium Equivalent to
(EQ)500 mg base/Vial Injectable; Injection Rising Pharma Holdings Inc. NDA 013217 SKELAXIN Metaxalone 800 mg Tablet; Oral King Pharmaceuticals Research and Development LLC, a subsidiary of Pfizer Inc. NDA 017710 NALFON Fenoprofen Calcium EQ 600 mg Base Tablet; Oral Dista Products Co., a division of Eli Lilly and Co. NDA 018716 TRANDATE Labetalol Hydrochloride 100 mg; 200 mg; 300 mg Tablet; Oral Alvogen Inc. NDA 018827 LOTRISONE Betamethasone Dipropionate; Clotrimazole EQ 0.05% Base; 1% Cream; Topical Organon LLC, a subsidiary of Organon and Co. NDA 020080 IMITREX Sumatriptan Succinate EQ 6 mg Base/0.5 mL (EQ 12 mg Base/mL) Injectable; Subcutaneous GlaxoSmithKline. NDA 020617 PYTEST KIT Urea, C-14 1 mCi Capsule; Oral Avent Inc. NDA 020763 AMERGE Naratriptan Hydrochloride EQ 1 mg Base; EQ 2.5 mg Base Tablet; Oral GlaxoSmithKline. NDA 020897 DITROPAN XL Oxybutynin Chloride 5 mg; 10 mg Tablet, Extended Release; Oral Janssen Pharmaceuticals Inc. NDA 020918 GLUCAGEN Glucagon Hydrochloride EQ 1 mg Base/Vial Injectable; Injection Novo Nordisk Pharmaceuticals Inc. NDA 020928 GLUCAGON Glucagon 1 mg/Vial Injectable; Injection Eli Lilly and Co. NDA 021615 RAZADYNE ER Galantamine Hydrobromide EQ 8 mg Base; EQ 16 mg Base; EQ 24 mg Base Capsule, Extended Release; Oral Janssen Pharmaceuticals Inc. NDA 021627 NAMENDA Memantine Hydrochloride 2 mg/mL Solution; Oral Allergan Sales LLC. NDA 021652 EPZICOM Abacavir Sulfate; Lamivudine EQ 600 mg Base, 300 mg Tablet; Oral ViiV Healthcare Co. NDA 021743 TARCEVA Erlotinib Hydrochloride EQ 25 mg Base; EQ 100 mg Base; EQ 150 mg Base Tablet; Oral OSI Pharmaceuticals LLC. NDA 021892 OSMOPREP Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate 0.398 grams (g)m; 1.102
(g)Tablet; Oral Salix Pharmaceuticals Inc. NDA 022013 OLUX E Clobetasol Propionate 0.05% Aerosol, Foam; Topical Mylan Pharmaceuticals Inc. NDA 022204 GELNIQUE Oxybutynin Chloride 10% (100 mg/Packet) Gel; Transdermal Abbvie Inc. NDA 022525 NAMENDA XR Memantine Hydrochloride 7 mg Capsule, Extended Release; Oral Abbvie Inc. NDA 050168 CORTISPORIN Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate 400 units/g 1%, EQ 3.5 mg Base/g, 5,000 units/g Ointment; Topical Monarch Pharmaceuticals LLC. NDA 050218 CORTISPORIN Hydrocortisone Acetate; Neomycin Sulfate; Polymyxin B Sulfate 0.5%, EQ 3.5 mg Base/g, 10,000 units/g Cream; Topical Monarch Pharmaceuticals LLC. NDA 050278 ACHROMYCIN V Tetracycline Hydrochloride 250 mg; 500 mg Capsule; Oral Avet Pharmaceuticals Inc. NDA 050578 FORTAZ Ceftazidime 500 mg/Vial; 1 g/Vial; 2 g/Vial; 6 g/Vial Injectable; Injection PAI Holdings LLC DBA Pharmaceutical Associates Inc. NDA 050679 MAXIPIME Cefepime Hydrochloride EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/Vial Injectable; Injection Hospira Inc. NDA 202543 LEVETIRACETAM IN SODIUM CHLORIDE Levetiracetam 250 mg/50 mL (5 mg/mL) Injectable; Intravenous HQ Specialty Pharma Corp. 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 drug products listed are unaffected by the discontinued marketing of the products subject to these applications. 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: August 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-17649 Filed 8-7-24; 8:45 am]
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