Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of January 14, 2019.
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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.
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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 § 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.
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|ANDA 073079||Loperamide Hydrochloride (HCl) Oral Solution, 1 milligram (mg)/5 milliliters||Allied Pharma, Inc., 20 Corrielle St., Fords, NJ 08863.|
|ANDA 076741||Ibuprofen Tablets USP, 100 mg||LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 11788.|
|ANDA 080210||Lidocaine Ointment, 5%||Belmora, LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202.|
|ANDA 085497||Phendimetrazine Tartrate Tablets, 35 mg||Virtus Pharmaceuticals, LLC, 2050 Cabot Blvd. West, 2nd Floor, Langhorne, PA 19047.|
|ANDA 085695||Phendimetrazine Tartrate Capsules, 35 mg||Do.|
|ANDA 086365||Phendimetrazine Tartrate Tablets, 35 mg||Do.|
|ANDA 086399||Theolair (theophylline) Tablets, 125 mg and 250 mg||Medicis Pharmaceutical Corp., c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.|
|ANDA 087378||Phendimetrazine Tartrate Extended-Release Capsules, 105 mg||Virtus Pharmaceuticals, LLC.|
|ANDA 202030||Bromfenac Sodium Ophthalmic Solution, Equivalent to 0.09% Acid||Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite 205, Berwyn, PA 19312.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 14, 2019. 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 January 14, 2019, 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.
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Dated: December 7, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-26947 Filed 12-12-18; 8:45 am]
BILLING CODE 4164-01-P