Document ID: FDA-2018-N-2156-0001
Agency: fda
Document Type: Notice
Title: Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two Abbreviated New Drug Applications
Posted Date: 2018-06-14T04:00Z

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12762]

[[Page 27784]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2156]

Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two 
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 two abbreviated new drug applications (ANDAs) 
from Ferring Pharmaceuticals, Inc. (Ferring). Ferring 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 16, 2018.

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: Ferring has informed FDA that the drug 
products listed in the table are no longer marketed and has requested 
that FDA withdraw approval of the applications under the process 
described in Sec.  314.150(c) (21 CFR 314.150(c)). Ferring 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.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
ANDA 073598...................  Menotropins (follicle-  Ferring
                                 stimulating hormone     Pharmaceuticals
                                 (FSH)/luteinizing       , Inc., 100
                                 hormone (LH)) for       Interpace
                                 Injection, 75           Pkwy.,
                                 international units     Parsippany, NJ
                                 (IU)/75 IU per vial.    07054.
ANDA 073599...................  Menotropins (FSH/LH)    Do.
                                 for Injection, 150 IU/
                                 150 IU per vial.
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    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
16, 2018. 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 July 16, 2018 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: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12762 Filed 6-13-18; 8:45 am]
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