Document ID: FDA-2019-N-4310-0001
Agency: fda
Document Type: Notice
Title: Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE
Posted Date: 2019-10-25T04:00Z

[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Page 57450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23309]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4310]

Allergan Pharmaceuticals International, LTD; Withdrawal of 
Approval of a New Drug Application for LO MINASTRIN FE

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 a new drug application (NDA) for LO MINASTRIN 
FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol 
and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate 
tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD, 
c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan). 
Allergan notified the Agency in writing that the drug product was no 
longer marketed and requested that the approval of the application be 
withdrawn.

DATES: Approval is withdrawn as of November 25, 2019.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: Allergan has informed FDA that LO MINASTRIN 
FE (ethinyl estradiol tablets, 0.01 mg; ethinyl estradiol and 
norethindrone acetate tablets, 0.01 mg/1 mg; and ferrous fumarate 
tablets, 75 mg) is no longer marketed and has requested that FDA 
withdraw approval of NDA 204654 under the process in Sec.  314.150(c) 
(21 CFR 314.150(c)). Allergan has also, by its request, waived its 
opportunity for a hearing. Withdrawal of approval of an application or 
abbreviated application under Sec.  314.150(c) is without prejudice to 
refiling.
    Therefore, approval of NDA 204654, and all amendments and 
supplements thereto, is hereby withdrawn as of November 25, 2019. 
Approval of the entire application is withdrawn, including any 
strengths and dosage forms inadvertently missing from this notice. 
Introduction or delivery for introduction into interstate commerce of a 
product without an approved new drug application violates section 
301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331(a) and (d)). Any Lo Minastrin Fe that is in inventory on November 
25, 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: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23309 Filed 10-24-19; 8:45 am]
 BILLING CODE 4164-01-P