| Page Range | 53068-53069 | |
| FR Document | 2018-22805 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Notices] [Pages 53068-53069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22805] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3761] Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 19, 2018. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. 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. [[Page 53069]] ---------------------------------------------------------------------------------------------------------------- Application No. Drug Applicant ---------------------------------------------------------------------------------------------------------------- NDA 006002....................... Aralen Hydrochloride (chloroquine Sanofi-Aventis, U.S., LLC, 55 Corporate hydrochloride (HCl)) Injection, Dr., Bridgewater, NJ 08807. Equivalent to (EQ) 40 milligram (mg) base/milliliter (mL); Aralen (chloroquine phosphate) Tablets, EQ 300 mg base. NDA 008107....................... Leucovorin calcium for Injection Hospira Inc., Subsidiary of Pfizer Inc., USP, EQ 60 mg base/vial for 235 East 42nd St., New York, NY 10017. solution, oral; EQ 3 mg base/mL injection; EQ 50 mg base/vial injection; EQ 100 mg base/vial injection; EQ 350 mg base/vial injection. NDA 009321....................... Cholografin Meglumine (iodipamide Bracco Diagnostics, Inc., 259 Prospect meglumine) Injection, 10.3% and Plains Rd., Monroe Township, NJ 08831. 52% (cholografin sodium, 20%). NDA 017566....................... Brevicon (ethinyl estradiol; Allergan Pharmaceuticals International, norethindrone) Tablets, 0.035 mg/ Ltd., c/o Allergan Sales, LLC, 2525 0.5 mg (21-Day Regimen). Dupont Dr., Irvine, CA 92612. NDA 018181....................... Mycelex (clotrimazole) Topical Bayer HealthCare LLC, 100 Bayer Blvd., 100 Solution, 1%. Bayer Rd., Pittsburgh, PA 15205. NDA 018182....................... Mycelex-7 (clotrimazole) Tablets, Do. 100 mg. NDA 018183....................... Mycelex (clotrimazole) Topical Do. Cream, 1%. NDA 018230....................... Mycelex-7 (clotrimazole) Topical Do. Vaginal Cream, 1%. NDA 018856....................... D-Xylose (xylose) Powder, 25 Lyne Laboratories, 10 Burke Dr., Brockton, grams (g)/bottle. MA 02301. NDA 018874....................... Calcijex (calcitriol) Injection, AbbVie, Inc., 1 North Waukegan Rd., North 0.001 mg/mL and 0.002 mg/mL. Chicago, IL 60064. NDA 020214....................... Zemuron (rocronium bromide) Organon USA Inc., Subsidiary of Merck & Injection, 50 mg/5 mL (10 mg/ Co., Inc., 2000 Galloping Hill Rd., mL); 10 mg/mL (10 mg/mL); 100 mg/ Kenilworth, NJ 07033. 10 mL (10 mg/mL). NDA 020389....................... Mycelex-7 Combination Pack Bayer HealthCare LLC. (clotrimazole) Topical Vaginal Cream and Tablets, 1%, 100 mg. NDA 020528....................... Mavik (trandolapril) Tablets, 1 AbbVie, Inc. mg, 2 mg, and 4 mg. NDA 020738....................... Teveten (eprosartan mesylate) Do. Tablets, 300 mg, 400 mg, and 600 mg. NDA 020863....................... Pletal (cilostazol) Tablets, 50 Otsuka Pharmaceutical Development and mg and 100 mg. Commercialization, Subsidiary of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rockville, MD 20850. NDA 021268....................... Teveten HCT (eprosartan mesylate AbbVie, Inc. and hydrochlorothiazide) Tablets, 600/12.5 mg and 600/25 mg. NDA 021410....................... Avandamet (rosiglitazone maleate GlaxoSmithKline, 1250 South Collegeville and metformin hydrochloride Rd., Collegeville, PA 19426. (HCl)) Tablets, 500 mg EQ 1 mg base; 500 mg EQ 2 mg base; 500 mg EQ 4 mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg base. NDA 021511....................... Copegus (ribavirin) Tablets, 200 Hoffmann La-Roche, Inc., Subsidiary of mg and 400 mg. Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080. NDA 021700....................... Avandaryl (glimepiride and SB Pharmco Puerto Rico Inc., Subsidiary of rosiglitazone maleate) Tablets, GlaxoSmithKline, 1250 South Collegeville 1 mg/4 mg; 2 mg/4 mg; 2 mg/8 mg; Rd., Collegeville, PA 19426. 4 mg/4 mg; 4 mg/8 mg. NDA 205123....................... Olysio (simeprevir sodium) Janssen Pharmaceuticals, Inc., 1000 U.S. Capsules, EQ 150 mg base. Rte. 202 South, Raritan, NJ 08869. ---------------------------------------------------------------------------------------------------------------- Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 19, 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 November 19, 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: October 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22805 Filed 10-18-18; 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 November 19, 2018. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 83 FR 53068 |