AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of May 11, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 040252 | Carisoprodol and Aspirin Tablets USP, 200 milligrams (mg)/325 mg | Oxford Pharmaceuticals, LLC, 301 Leaf Lake Pkwy., Birmingham, AL 35211. |
| ANDA 040283 | Carisoprodol, Aspirin, and Codeine Phosphate Tablets USP, 200 mg/325 mg/16 mg | Do. |
| ANDA 061214 | Tetracycline Hydrochloride (HCl) Capsules USP, 250 mg and 500 mg | Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228. |
| ANDA 061682 | Tetracycline HCl Tablets, 500 mg | Mylan Pharmaceuticals Inc., P.O. Box 4293, Morgantown, WV 26505. |
| ANDA 062212 | Totacillin (ampicillin/ampicillin trihydrate) Capsules, Equivalent to (EQ) 250 mg base and EQ 500 mg base | GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709. |
| ANDA 062654 | Rocephin (ceftriaxone sodium) for Injection, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial | Hoffman La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way, MS 241B, South San Francisco, CA 94080. |
| ANDA 062680 | Oxacillin Sodium for Injection (Pharmacy Bulk Package) | ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17 North, Paramus, NJ 07653. |
| ANDA 065124 | Cefotaxime for Injection USP, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial | Lupin Ltd., c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 24th Floor, Baltimore, MD 21202. |
| ANDA 065263 | Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package) | Do. |
| ANDA 074845 | Diltiazem HCl Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg | Biovail Corp. International, Subsidiary of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 077173 | Ondansetron Injection USP, EQ 2 mg base/milliliter (mL) | Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 078598 | Ciprofloxacin Ophthalmic Solution USP, EQ 0.3% base | Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite 205, Berwyn, PA 19312. |
| ANDA 078805 | Irinotecan HCl Injection, 20 mg/mL | Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 086024 | Capital and Codeine (acetaminophen and codeine phosphate) Oral Suspension USP, 120 mg/12 mg per 5 mL | Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 091180 | Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, EQ 2% base/EQ 0.5% base | Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242. |
| ANDA 203176 | Nevirapine Tablets USP, 200 mg | Technology Organized, LLC, 9191 Point Replete Dr., Fort Belvoir, VA 22060. |
| ANDA 204900 | Amlodipine Besylate Tablets USP, EQ 2.5 mg base, EQ 5 mg base, and EQ 10 mg base | Sovereign Pharmaceuticals, LLC, 7590 Sand St., Fort Worth, TX 76118. |
| ANDA 209480 | Clozapine Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg | Zydus Pharmaceuticals USA, Inc., 73 Route 31 North, Pennington, NJ 08534. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 11, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on May 11, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07440 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P