Document ID: FDA-2021-N-1287-0001
Agency: fda
Document Type: Notice
Title: Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Posted Date: 2021-12-13T05:00Z

[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Page 70852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26892]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1287]

Actavis LLC, et al.; Withdrawal of Approval of Six 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 six 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 12, 2022.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [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 202603..................  Methoxsalen        Actavis LLC, (an
                                Capsules, 10       indirect, wholly
                                milligrams (mg).   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Bldg. A, Parsippany,
                                                   NJ 07054.
ANDA 205274..................  Amoxicillin        Hikma Pharmaceuticals
                                Tablets, 125 mg    LLC, 1809 Wilson Rd.,
                                and 250 mg.        Columbus, OH 43228.
ANDA 205513..................  Carisoprodol       Strides Pharma Global
                                Tablets, 250 mg    Pte. Limited, U.S.
                                and 350 mg.        Agent, Strides Pharma
                                                   Inc., 2 Tower Center
                                                   Blvd., Suite 1102,
                                                   East Brunswick, NJ
                                                   08816.
ANDA 206410..................  Itraconazole       Do.
                                Capsules, 100 mg.
ANDA 207536..................  Flucytosine        Do.
                                Capsules, 250 mg
                                and 500 mg.
ANDA 208227..................  Dutasteride        Do.
                                Capsules, 0.5 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 12, 2022. 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 January 12, 2022, 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, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26892 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P