[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25811-25812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1707]


Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 
Five Abbreviated New Drug Applications for Pemoline Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of five abbreviated new drug applications (ANDAs) for products 
containing pemoline. The holders of the applications requested 
withdrawal of the applications and have waived their opportunity for a 
hearing.

DATES: Approval is withdrawn as of June 4, 2019.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: FDA approved the following ANDAs for 
pemoline tablets for the conditions of use in the labeling of new drug 
application (NDA) 016832, the reference listed drug on which these 
ANDAs relied:

 ANDA 075030 approved on January 29, 1999
 ANDA 075287 approved on September 18, 2000
 ANDA 075595 approved on February 28, 2000

    FDA approved the following ANDAs for pemoline chewable tablets for 
the conditions of use in the labeling of NDA 017703, the reference 
listed drug on which these ANDAs relied:

 ANDA 075555 approved on February 18, 2000
 ANDA 075678 approved on July 26, 2000

    On October 24, 2005, FDA issued a Postmarket Drug Safety 
Information for Healthcare Professionals communication stating its 
conclusion that the overall liver toxicity risk of CYLERT (NDAs 016832 
and 017703) and generic pemoline products outweighed the benefits of 
these products (https://wayback.archive-it.org/7993/20171114124349/
https://www.fda.gov/DrugsDrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/

[[Page 25812]]

ucm126461.htm). The applicants and other holders of approved 
applications for pemoline products ceased marketing the products at 
that time.
    On August 10, 2018, the applicants listed in the table below 
requested that FDA withdraw approval of the pemoline ANDAs listed in 
the table under Sec.  314.150(d) (21 CFR 314.150(d)), and, in doing so, 
waived their opportunity for a hearing. For the reasons discussed 
above, which the applicants do not dispute in their withdrawal request 
letters, and pursuant to the applicants' requests, FDA is withdrawing 
approval of the ANDAs listed in the table, and all amendments and 
supplements thereto, under Sec.  314.150(d). Tablet strengths listed in 
the table below include all strengths FDA has identified as being 
previously approved under these ANDAs. In each case, approval of the 
entire application is withdrawn, including any strengths inadvertently 
missing from the table. Distribution of these products in interstate 
commerce without an approved application is illegal and subject to 
regulatory action (see sections 505(a) and 301(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d), respectively).

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        Application No.                 Drug              Applicant
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ANDA 075030...................  Pemoline Tablets,    Teva
                                 18.75 mg, 37.5 mg,   Pharmaceuticals
                                 and 75 mg.           USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 075287...................  Pemoline Tablets,    Watson
                                 18.75 mg, 37.5 mg,   Laboratories,
                                 and 75 mg.           Inc., 425 Privet
                                                      Rd., Horsham, PA
                                                      19044.
ANDA 075555...................  Pemoline Chewable    Teva
                                 Tablets, 37.5 mg.    Pharmaceuticals
                                                      USA, Inc.
ANDA 075595...................  Pemoline Tablets,    Actavis Elizabeth
                                 18.75 mg, 37.5 mg,   LLC, 425 Privet
                                 and 75 mg.           Rd., Horsham, PA
                                                      19044.
ANDA 075678...................  Pemoline Chewable    Do.
                                 Tablets, 37.5 mg.
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    Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11519 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P


