Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams, 16685 [2013-06144]
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Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
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[FR Doc. 2013–06167 Filed 3–15–13; 8:45 am]
BILLING CODE 4160–01–P
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.
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be withdrawn and waived its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
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
16685
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 ExtendedRelease 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 ExtendedRelease Tablets 300 mg from the market
after results of an FDA-sponsored
bioequivalence study showed that
Impax’s Bupropion HCl ExtendedRelease 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 § 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
§ 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 ExtendedRelease 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]
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
