Document ID: FDA-2018-N-0409-0001
Agency: fda
Document Type: Notice
Title: Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an  Abbreviated New Drug Application for PEMOLINE Tablets, 18.75  Milligrams, 37.5 Milligrams, and 75 Milligrams
Posted Date: 2018-02-13T05:00Z

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02925]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0409]

Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an 
Abbreviated New Drug Application for PEMOLINE Tablets, 18.75 
Milligrams, 37.5 Milligrams, and 75 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of abbreviated new drug application (ANDA) 075726 for PEMOLINE 
Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt 
Pharmaceuticals, LLC (Mallinkrodt). Mallinkrodt requested withdrawal of 
this application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of February 13, 2018.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796-
3600.

SUPPLEMENTARY INFORMATION: FDA approved ANDA 075726 for PEMOLINE 
Tablets, 18.75 mg, 37.5 mg, and 75 mg, on March 30, 2001, for the 
conditions of use in the labeling of new drug application (NDA) 016832, 
the reference listed drug on which it relied. However, on October 24, 
2005, FDA announced its concern that the overall liver toxicity risk of 
CYLERT (NDA 016832) and generic pemoline products outweighed the 
benefits of these products. Mallinkrodt and other holders of approved 
applications for PEMOLINE products ceased marketing them at that time. 
Indeed, Mallinkrodt stated in its May 15, 2013, request for withdrawal 
of approval of ANDA 075726 that it had never manufactured or 
distributed its product after it received approval of its application.
    In the Federal Register of October 4, 2016 (81 FR 68427), FDA 
erroneously included ANDA 075726 in a list of drug applications for 
which approval was being withdrawn under Sec.  314.150(c) (21 CFR 
314.150(c)). In a separate notice published in this issue of the 
Federal Register, FDA corrects that notice to remove ANDA 075726 from 
the list of applications whose approval was withdrawn under Sec.  
314.150(c). In addition, for the reasons discussed above, and pursuant 
to Mallinkrodt's request, FDA is withdrawing approval of ANDA 075726, 
and all amendments and supplements thereto, under Sec.  314.150(d). 
Distribution of PEMOLINE Tablets, 18.75 mg, 37.5 mg, and 75 mg, in 
interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02925 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P