[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)] [Notices] [Pages 28950-28951] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-10367] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2020-N-1117] Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of June 15, 2020. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301- 796-3137. 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 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 ------------------------------------------------------------------------ NDA 011529............... Parafon Forte DSC Janssen (chlorzoxazone), Pharmaceuticals, Caplets, 500 Inc., 1000 Route 202 milligrams (mg). South, P.O. Box 300, Raritan, NJ 08869. NDA 018029............... Ritalin-SR Novartis (methylphenidate Pharmaceuticals hydrochloride (HCl)) Corp., 1 Health Extended-Release Plaza, East Hanover, Tablets, 20 mg. NJ 07936. NDA 018082............... Depakene (valproic AbbVie Inc., 1 North acid) Oral Solution, Waukegan Rd., North 250 mg/5 milliliter Chicago, IL 60064. (mL). NDA 019579............... Terazol 7 Janssen (terconazole) Vaginal Pharmaceuticals, Cream, 0.4%. Inc., 1125 Trenton- Harbourton Rd., Titusville, NJ 08560. NDA 020119............... Vumon (teniposide) HQ Specialty Pharma, Injection, 10 mg/mL. 120 Route 17 North, Paramus, NJ 07652. NDA 020388............... Navelbine (vinorelbine Pierre Fabre tartrate) Injection, Medicament c/o Equivalent to (EQ) 10 Pierre Fabre mg/mL base. Pharmaceuticals, Inc., 8 Campus Dr., Suite 202, Parsippany, NJ 07054. NDA 020741............... Prandin (repaglinide) Gemini Laboratories, Tablets, 0.5 mg, 1.0 LLC, 400 Crossing mg, and 2.0 mg. Blvd., 5th Floor, Bridgewater, NJ 08807. NDA 020920............... Natrecor (nesiritide) Scios, LLC, 1125 Injection, 1.5 mg/ Trenton-Harbourton vial. Rd., Titusville, NJ 08560. NDA 021001............... Axert (almotriptan Janssen malate) Tablets, EQ Pharmaceuticals, 6.25 mg base and EQ Inc. 12.5 mg base. NDA 021203............... Tricor (fenofibrate) AbbVie Inc. Tablets, 54 mg and 160 mg. NDA 021543............... Striant (testosterone Auxilium buccal system) Pharmaceuticals, Extended-Release Inc., 1400 Atwater Tablets, 30 mg. Dr., Malvern, PA 19355. NDA 021604............... Children's ElixSure IB Moberg Pharma North (ibuprofen) Oral America LLC, 7 East Suspension, 100mg/5 Frederick Place, mL. Suite 100, Cedar Knolls, NJ 07927. [[Page 28951]] NDA 021611............... Opana (oxymorphone Endo Pharmaceuticals, HCl) Tablets, 5mg and Inc., 1400 Atwater 10mg. Dr., Malvern, PA 19355. NDA 022321............... Embeda (morphine Alpharma sulfate and Pharmaceuticals, naltrexone HCl) LLC, 235 East 42nd Extended-Release St., New York, NY Capsules, 20 mg/0.8 10017. mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg. NDA 022510............... Abstral (fentanyl) Sentynl Therapeutics, Sublingual Inc., 420 Stevens Tablets,100 Ave., Suite 200, micrograms (mcg), 200 Solana Beach, CA mcg, 300 mcg, 400 92075. mcg, 600 mcg, and 800 mcg. NDA 050641............... Monodox (doxycycline Aqua Pharmaceuticals, monohydrate) LLC, 707 Eagleview Capsules, EQ 50mg Blvd., Suite 200, base, EQ 75mg base, Exton, PA 19341. and EQ 100mg base. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 15, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. 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 June 15, 2020 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: May 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-10367 Filed 5-13-20; 8:45 am] BILLING CODE 4164-01-P