| Page Range | 39102-39103 | |
| FR Document | 2018-16985 |
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)] [Notices] [Pages 39102-39103] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16985] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2485] Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of September 7, 2018.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, [email protected]. 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 described in Sec. 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 Sec. 314.150(c) is without prejudice to refiling. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 061467................... Pyocidin-Otic Fougera (hydrocortisone and Pharmaceuticals polymyxin B sulfate) , Inc., 60 Otic Solution, 5 Baylis Rd., milligrams (mg)/ P.O. Box 2006, 10,000 units per Melville, NY milliliter (mL). 11747. ANDA 061653................... Tetrex (tetracycline Bristol-Myers phosphate complex) Squibb Co., Capsules, Equivalent P.O. Box 4000, to (EQ) 100 mg Princeton, NJ Hydrochloride (HCl), 08543. EQ 250 mg HCl and EQ 500 mg HCl. ANDA 061658................... Bristacycline Do. (tetracycline HCl) Capsules, 250 mg and 500 mg. ANDA 061711................... Penicillin V Potassium Do. Tablets. ANDA 061721................... Ampicillin Capsules, Do. 250 mg and 500 mg. ANDA 061726................... Azotrex Do. (phenazopyridine HCl, sulfamethizole and tetracycline phosphate complex) Capsules, 50 mg/250 mg/125 mg. ANDA 061790................... Hetacillin Potassium.. Do. ANDA 061887................... Bristamycin Do. (erythromycin stearate) Tablets, EQ 250 mg base. ANDA 061888................... Bristacycline Do. (tetracycline HCl) Capsules, 250 mg and 500 mg. ANDA 061889................... Tetrex (tetracycline Do. phosphate complex) Capsules, EQ 250 mg HCl and EQ 500 mg HCl. ANDA 061890................... Azotrex Do. (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 mg/250 mg/125 mg. ANDA 061891................... Tetrex-S Do. (tetracycline) Syrup, 125 mg/5 mL. ANDA 061975................... Cephradine Powder for Do. Injection. ANDA 062168................... Cephradine Tablets.... Do. ANDA 062259................... Amphotericin B for Use Do. in Parenteral Products. ANDA 062543................... Mycolog (nystatin, Do. neomycin sulfate, gramicidin, and triamcinolone acetonide) Ointment. ANDA 071793................... Foamcoat (aluminum Guardian Drug hydroxide; magnesium Co., 2 Charles trisilicate) Chewable Court, Dayton, Tablets, 80 mg/20 mg NJ 08810. (OTC). ANDA 072035................... Nuprin (ibuprofen) Bristol-Myers Tablets, 200 mg. Squibb Co. ANDA 072036................... Nuprin (ibuprofen) Do. Tablets, 200 mg. ANDA 074911................... Phrenilin with Valeant Caffeine and Codeine Pharmaceuticals (acetaminophen, North America, butalbital, caffeine, LLC, 400 and codeine Somerset phosphate) Capsules, Corporate 325 mg/50 mg/40 mg/30 Blvd., mg. Bridgewater, NJ 08807. ANDA 074944................... Atracurium Besylate Watson Injection, 10 mg/mL. Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 075206................... Cytosar-U (cytarabine) Teva for Injection USP, Pharmaceuticals 100 mg/vial, 500 mg/ USA, Inc., 425 vial, 1 gram (g)/ Privet Rd., vial, and 2 g/vial. Horsham, PA 19044. ANDA 077337................... Rosiglitazone Maleate Do. and Metformin HCl Tablets, EQ 1 mg base/ 500 mg, EQ 2 mg base/ 500 mg, EQ 4 mg base/ 500 mg, EQ 2 mg base/ 1 g, and EQ 4 mg base/ 1 g. ANDA 077930................... Meloxicam Tablets, 7.5 Impax mg and 15 mg. Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. ANDA 080658................... Procaine HCl Watson Injection, 1% and 2%. Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 083128................... Hydrocortisone Acetate Do. Injectable Suspension, 25 mg/mL. ANDA 090181................... Ifosfamide for Fresenius Kabi Injection, 1 g/20 mL USA, LLC, Three and 3 g/60 mL. Corporate Dr., Lake Zurich, IL 60047. ------------------------------------------------------------------------ [[Page 39103]] Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of September 7, 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 September 7, 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: August 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16985 Filed 8-7-18; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of September 7, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 39102 |