83 FR 64131 - Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 239 (December 13, 2018)

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64131-64132]
From the Federal Register Online  [www.thefederalregister.org]
[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 14, 2019.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.

------------------------------------------------------------------------
         Application No.                 Drug              Applicant
------------------------------------------------------------------------
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.,
                                                       #1000, Arlington,
                                                       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]
 BILLING CODE 4164-01-P