[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Page 19626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0252]


Watson Laboratories, Inc.; Withdrawal of Approval of Bupropion 
Hydrochloride Extended-Release Tablets, 300 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of Bupropion Hydrochloride (HCl) Extended-Release (ER) Tablets, 300 
Milligrams (mg) (Bupropion HCl ER Tablets, 300 mg), under abbreviated 
new drug application (ANDA) 77-715, held by Watson Laboratories, Inc. 
(Watson), 4955 Orange Dr., Fort Lauderdale, FL 33314. Watson has 
voluntarily requested that approval for this product be withdrawn and 
waived its opportunity for a hearing.

DATES: Effective April 9, 2014.

FOR FURTHER INFORMATION CONTACT: Carolina M. Wirth, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6282, Silver Spring, MD 20993-0002, 301-
796-3602.

SUPPLEMENTARY INFORMATION: FDA approved ANDA 77-715 for Bupropion HCl 
ER Tablets, 300 mg on June 13, 2007, under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). 
Bupropion HCl ER Tablets, 300 mg was indicated for the treatment of 
major depressive disorder. On September 24, 2013, FDA requested that 
Watson voluntarily withdraw its Bupropion HCl ER Tablets, 300 mg from 
the market after results of a bioequivalence study conducted by Watson 
showed that the firm's Bupropion HCl ER Tablets, 300 mg are not 
therapeutically equivalent to the 300-mg strength of the reference 
listed drug. In a letter dated September 30, 2013, Watson requested 
that FDA withdraw approval of the 300-mg strength of Bupropion HCl ER 
Tablets, approved under ANDA 77-715, under Sec.  314.150(d) (21 CFR 
314.150(d)). In that letter, Watson also waived its opportunity for a 
hearing. The Agency acknowledged Watson's requests in a letter dated 
October 4, 2013.
    Therefore, under section 505(e) of the FD&C Act (21 U.S.C. 355(e)) 
and Sec.  314.150(d), and under authority delegated by the Commissioner 
to the Director, Center for Drug Evaluation and Research, approval of 
the 300-mg strength of Bupropion HCl Extended-Release Tablets under 
ANDA 77-715 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: April 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07897 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P