Document ID: FDA-2021-N-0033-0001
Agency: fda
Document Type: Notice
Title: Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
Posted Date: 2021-03-05T05:00Z

[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12950-12951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0033]

Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval 
of Seven 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 seven 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 5, 2021.

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, Martha.Nguyen@fda.hhs.gov.

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 065428..................  Cefprozil Tablets,    Morton Grove
                                250 milligrams (mg)   Pharmaceuticals
                                and 500 mg.           Inc./Wockhardt USA
                                                      LLC., 6451 Main
                                                      St., Morton Grove,
                                                      IL 60053.
ANDA 077699..................  Mefloquine            Hikma
                                Hydrochloride (HCl)   Pharmaceuticals
                                Tablets, 250 mg.      USA Inc., 1809
                                                      Wilson Rd.,
                                                      Columbus, OH
                                                      43228.
ANDA 078383..................  Pioglitazone HCl      Neopharma Inc., 211
                                Tablets, Equivalent   College Road East,
                                to (EQ) 15 mg base;   Suite 101,
                                EQ 30 mg base; EQ     Princeton, NJ
                                45 mg base.           08540.
ANDA 078953..................  Irinotecan HCl         Do.
                                Injection, 40 mg/2
                                milliliters (mL)
                                (20 mg/mL) and 100
                                mg/5 mL (20 mg/mL).
ANDA 079049..................  Alendronate Sodium     Do.
                                Tablets, EQ 5 mg
                                base; EQ 10 mg
                                base; EQ 35 mg
                                base; EQ 70 mg base.

[[Page 12951]]

 
ANDA 090732..................  Anastrozole Tablets,   Do.
                                1 mg.
ANDA 203161..................  Irbesartan Tablets,    Do.
                                75 mg, 150 mg, and
                                300 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of April 
5, 2021. 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 April 5, 2021 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: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04520 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P