Document ID: FDA-2017-N-0002-0006
Agency: fda
Document Type: Notice
Title: Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE
Posted Date: 2017-08-30T04:00Z

[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Page 41273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18375]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0002]

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

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 
PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, 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of this application be withdrawn and has waived its opportunity for a 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: August 30, 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 March 6, 2009, FDA approved abbreviated 
new drug application (ANDA) 078311 for PROPRANOLOL HYDROCHLORIDE 
Extended-Release Capsules, USP, 60 milligrams (mg), 80 mg, 120 mg, and 
160 mg. In a letter dated August 9, 2011, FDA informed Upsher-Smith 
that it had concerns about the validity of bioequivalence data 
submitted with ANDA 078311 from studies conducted by a certain contract 
research organization, establishing bioequivalence of Upsher-Smith's 
product to the reference listed drug (RLD), INDERAL LA (propranolol 
hydrochloride) Extended Release Capsules, 60 mg, 80 mg, 120 mg, and 160 
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 
submitted new fasted and fed bioequivalence studies to supplement ANDA 
078311 in paper format on August 29, 2013, and in electronic format on 
May 9, 2014.
    On April 14, 2016, FDA informed Upsher-Smith that the applicant's 
fed bioequivalence study failed to meet FDA's bioequivalence criteria 
and, therefore, requested that Upsher-Smith voluntarily seek withdrawal 
of ANDA 078311 under Sec.  314.150(d) (21 CFR 314.150(d)).
    In a letter dated May 13, 2016, Upsher-Smith requested that FDA 
withdraw approval of ANDA 078311 for PROPRANOLOL HYDROCHLORIDE 
Extended-Release Capsules under Sec.  314.150(d) because the new 
bioequivalence data did not demonstrate therapeutic equivalence of its 
product to the RLD, INDERAL LA. In that letter, Upsher-Smith also 
waived any opportunity for a hearing otherwise provided under Sec.  
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 Sec.  314.150(d), and 
under authority delegated by the Commissioner of Food and Drugs to the 
Director, Center for Drug Evaluation and Research, approval of ANDA 
078311, 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 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18375 Filed 8-29-17; 8:45 am]
 BILLING CODE 4164-01-P