Document ID: FDA-2017-N-3966-0001
Agency: fda
Document Type: Notice
Title: Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON
Posted Date: 2017-08-16T04:00Z

[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38911-38912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17301]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3966]

Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an 
Abbreviated New Drug Application for ZALEPLON

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
withdrawing approval of an abbreviated new drug application (ANDA) for 
ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, held by Upsher-Smith 
Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 
55369. Upsher-Smith has voluntarily requested that approval of this 
application be withdrawn, and has waived its opportunity for a hearing.

DATES: Effective August 16, 2017.

FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-9585.

SUPPLEMENTARY INFORMATION: On June 6, 2008, FDA approved ANDA 078706 
for ZALEPLON Capsules, 5 mg and 10 mg, submitted by Upsher-Smith. 
According to annual reports Upsher-Smith filed with the Agency, Upsher-
Smith stopped distributing these products by April 6, 2010. In a letter 
dated August 9, 2011, FDA informed Upsher-Smith that it had concerns 
about the validity of bioequivalence data submitted with ANDA 078706 
from studies conducted by a certain contract research organization, 
establishing bioequivalence of Upsher-Smith's product to the reference 
listed drug, SONATA (ZALEPLON) Capsules, 5 mg and 10 mg. In that 
letter, FDA directed Upsher-Smith to supplement its ANDA with either: 
(1) New bioequivalence studies or (2) re-assays of the samples from the 
original bioequivalence studies. Upsher-Smith did not respond to this 
letter. FDA then sent another letter to Upsher-Smith on August 19,

[[Page 38912]]

2016, requesting that Upsher-Smith provide the requested bioequivalence 
data within 30 calendar days or voluntarily seek withdrawal of ANDA 
078706 under section 314.150(d) (21 CFR 314.150(d)).
    In a letter dated September 15, 2016, Upsher-Smith informed FDA 
that it did not intend to submit the requested bioequivalence data and 
requested that the Agency withdraw approval of ANDA 078706 for ZALEPLON 
Capsules under section 314.150(d). In that letter, Upsher-Smith also 
waived any opportunity for a hearing otherwise provided under section 
314.150(a).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and 314.150(d), approval of 
ANDA 078706, and all amendments and supplements thereto, is withdrawn 
(see DATES). Distribution of this product 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: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17301 Filed 8-15-17; 8:45 am]
 BILLING CODE 4164-01-P