| Page Range | 49102-49103 | |
| FR Document | 2018-21199 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49102-49103] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21199] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3569] GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 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 24 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of October 29, 2018.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 applicants 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 061336............ Bactocill (oxacillin GlaxoSmithKline, LLC, sodium) Capsules, Five Moore Dr., P.O. Equivalent to (EQ) 250 Box 13398, Research milligrams (mg) base Triangle Park, NC and EQ 500 mg base. 27709. ANDA 061773............ Kefzol (cefazolin) for ACS Dobfar S.p.A., c/o Injection USP, EQ 250 Interchem Corp., 120 mg base/vial, EQ 500 Rte. 17 North, mg base/vial, EQ 1 Paramus, NJ 07652. gram (g) base/vial, EQ 10 g base/vial, and EQ 20 g base/vial. ANDA 062615............ Nystatin Vaginal Odyssey Inserts USP, 100,000 Pharmaceuticals, units. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 063304............ Clindamycin Phosphate Wockhardt Bio AG, c/o Topical Solution USP, Morton Grove EQ 1% base. Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. ANDA 065001............ Cefuroxime for Fresenius Kabi USA, Injection USP, EQ LLC, Three Corporate 750mg base/vial and EQ Dr., Lake Zurich, IL 1.5 g base/vial. 60047. ANDA 065002............ Cefuroxime for Do. Injection USP, EQ 7.5 g base/vial (Pharmacy Bulk Package). ANDA 070736............ Ibuprofen Tablets USP, Aurolife Pharma, LLC, 300 mg, 400 mg, and 279 Princeton 600 mg. Hightstown Rd., East Windsor, NJ 08520. ANDA 071202............ Sensorcaine--MPF Spinal Fresenius Kabi USA, (bupivacaine LLC. hydrochloride (HCl)) in Dextrose Injection 8.25% USP, 0.75%. ANDA 071846............ Nitroglycerin in Hospira, Inc., 275 Dextrose 5% Injection, North Field Dr., 10 mg/100 milliliter Bldg. H1, Lake (mL). Forest, IL 60045. ANDA 071847............ Nitroglycerin in Do. Dextrose 5% Injection, 20 mg/100 mL. ANDA 071848............ Nitroglycerin in Do. Dextrose 5% Injection, 40 mg/100 mL. ANDA 072629............ Albuterol Tablets USP, Watson Laboratories, EQ 2 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074991............ Loperamide HCl Oral Duramed Solution, 1 mg/5 mL. Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. [[Page 49103]] ANDA 077312............ Fentanyl Citrate Troche/ Par Pharmaceutical, Lozenge, EQ 0.2 mg Inc., One Ram Ridge base, EQ 0.4 mg base, Rd., Chestnut Ridge, EQ 0.6 mg base, EQ 0.8 NY 10977. mg base, EQ 1.2 mg, and EQ 1.6 mg base. ANDA 077853............ Metformin HCl Tablets Provident USP, 500 mg, 850 mg, Pharmaceutical, Inc., and 1 g. c/o Vintage Pharmaceuticals, LLC, 1400 Atwater Dr., Malvern, PA 19355. ANDA 080355............ Hydrocortisone Tablets Watson Laboratories, USP, 20 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., Morris Corporate Center III, 400 Interpace Pkwy., Parsippany, NJ 07054. ANDA 080377............ Lidocaine HCl with Watson Laboratories, Epinephrine Injection, Inc., Subsidiary of 1%; 0.01 mg/mL and 2%; Teva Pharmaceuticals 0.01 mg/mL. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 087100............ Chlorthalidone Tablets Do. USP, 25 mg. ANDA 087211............ Methocarbamol and Ivax Pharmaceuticals, Aspirin Tablets, 400 Inc., Subsidiary of mg/325 mg. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 090184............ Podofilox Topical Bausch & Lomb, Inc., Solution, 0.5%. Subsidiary of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 202002............ Imiquimod Cream, 5%.... Strides Pharma Global Pte Ltd., c/o Strides Pharma, Inc., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816. ANDA 203247............ Sodium Fluoride F-18 University of Texas MD Injection, 10-200 Anderson Cancer millicurie (mCi)/mL. Center, Cyclotron Radiochemistry Facility, 1881 East Rd., Unit 1903, Houston, TX 77054. ANDA 203933............ Ammonia N-13 Injection, Do. 3.75-37.5 mCi/mL. ANDA 205072............ Cefadroxil Capsules CSPC Ouyi USP, EQ 500 mg base. Pharmaceutical Co., Ltd., c/o Megalith Pharmaceuticals, Inc., 9625 Hillside Rd., Rancho Cucamonga, CA 91737. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of October 29, 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 October 29, 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: September 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21199 Filed 9-27-18; 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 October 29, 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 49102 |