
[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Page 16685]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0233]


Impax 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 Tablets, 300 
Milligrams (mg) (Bupropion HCl Extended-Release Tablets 300 mg), under 
Abbreviated New Drug Application (ANDA) 77-415, held by Impax 
Laboratories, Inc. (Impax), 30831 Huntwood Ave., Hayward, CA 94544, and 
marketed under the name BUDEPRION XL. Impax has voluntarily requested 
that approval for this product be withdrawn and waived its opportunity 
for a hearing.

DATES: Effective March 18, 2013.

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 77-415 for Bupropion HCl 
Extended-Release Tablets 300 mg (marketed under the name BUDEPRION XL) 
on December 15, 2006 pursuant to section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). Bupropion HCl 
Extended-Release Tablets 300 mg was indicated for the treatment of 
major depressive disorder. On September 27, 2012, FDA requested that 
Impax voluntarily withdraw its Bupropion HCl Extended-Release Tablets 
300 mg from the market after results of an FDA-sponsored bioequivalence 
study showed that Impax's Bupropion HCl Extended-Release Tablets 300 mg 
are not therapeutically equivalent to the 300-mg strength of the 
reference listed drug. In a letter dated September 30, 2012, Impax 
requested that FDA withdraw approval of the 300-mg strength of 
Bupropion HCl Extended Release Tablets, approved under ANDA 77-415, 
pursuant to Sec.  314.150(d) (21 CFR 314.150(d)). In that letter, Impax 
also waived its opportunity for a hearing. The Agency acknowledged 
Impax's requests in a letter dated November 2, 2012.
    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 77-415 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: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06144 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P


