Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018)
Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)
Notices
Pages 64131-64132
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-26947
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-N-4416
Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 14, 2019.
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.
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Application No. Drug Applicant
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ANDA 073079..................... Loperamide Allied Pharma,
Hydrochloride Inc., 20
(HCl) Oral Corrielle St.,
Solution, 1 Fords, NJ 08863.
milligram (mg)/5
milliliters.
ANDA 076741..................... Ibuprofen Tablets LNK International,
USP, 100 mg. Inc., 145
Ricefield Ln.,
Hauppauge, NY
11788.
ANDA 080210..................... Lidocaine Belmora, LLC, 2231
Ointment, 5%. Crystal Dr.,
VA 22202.
ANDA 085497..................... Phendimetrazine Virtus
Tartrate Tablets, Pharmaceuticals,
35 mg. LLC, 2050 Cabot
Blvd. West, 2nd
Floor, Langhorne,
PA 19047.
ANDA 085695..................... Phendimetrazine Do.
Tartrate
Capsules, 35 mg.
ANDA 086365..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 086399..................... Theolair Medicis
(theophylline) Pharmaceutical
Tablets, 125 mg Corp., c/o
and 250 mg. Valeant
Pharmaceuticals
North America,
LLC, 400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 087378..................... Phendimetrazine Virtus
Tartrate Extended- Pharmaceuticals,
Release Capsules, LLC.
105 mg.
ANDA 202030..................... Bromfenac Sodium Amring
Ophthalmic Pharmaceuticals,
Solution, Inc., 1235
Equivalent to Westlakes Dr.,
0.09% Acid. Suite 205,
Berwyn, PA 19312.
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Page 64132
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.
Dated: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-26947 Filed 12-12-18; 8:45 am
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