Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules, 40367 [2012-16597]
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Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
requirements under the FD&C Act
relating to drug products. This
conclusion was based on the fact that
Dr. Justice had legal and professional
obligations to ensure that he submitted
accurate medical claims for procedures
he performed, as well as administering
medicines that were appropriate for his
patients’ condition, which he knowingly
and willingly disregarded, as well as the
fact that Dr. Justice intentionally billed
for different FDA-regulated drug
products than what he wrote
prescriptions for. Therefore, FDA had
reason to believe that, if Dr. Justice were
to provide services to a person that has
an approved or pending drug
application, he may violate
requirements under the FD&C Act
relating to drug products. The proposal
offered Dr. Justice an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. The proposal
was received on March 29, 2012. Dr.
Justice failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and has waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(b)(2)(B)(ii)(I)
of the FD&C Act, under authority
delegated to the Director (Staff Manual
Guide 1410.35), finds that Glen R.
Justice has been convicted of five counts
of a felony under Federal law for
conduct involving health care fraud,
and, on the basis of the conviction and
other information, finds that Dr. Justice
has demonstrated a pattern of conduct
sufficient to find that there is reason to
believe he may violate requirements
under the FD&C Act relating to drug
products.
As a result of the foregoing finding,
Dr. Justice is debarred for 25 years from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B), (c)(2)(A)(ii),
and 201(dd) of the FD&C Act (21 U.S.C.
335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))).
Any person with an approved or
pending drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
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16:20 Jul 06, 2012
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uses the services of Dr. Justice, in any
capacity during Dr. Justice’s debarment,
will be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21
U.S.C. 335b(a)(6))). If Dr. Justice
provides services in any capacity to a
person with an approved or pending
drug product application during his
period of debarment he will be subject
to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Dr. Justice during his period of
debarment (section 306(c)(1)(A) of the
FD&C Act).
Any application by Dr. Justice for
special termination of debarment under
section 306(d)(4) of the FD&C Act (21
U.S.C. 335a(d)(4)) should be identified
with Docket No. FDA–2011–N–0860
and sent to the Division of Dockets
Management (see ADDRESSES). All such
submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 22, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–16600 Filed 7–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0690]
40367
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In June
1998, Wyeth voluntarily withdrew
DURACT (bromfenac sodium) Capsules
from the market. DURACT (bromfenac
sodium) Capsules, a nonsteroidal antiinflammatory drug indicated for the
short-term management of acute and
chronic pain, were withdrawn from the
market after FDA and Wyeth received
postmarketing reports of rare, severe
liver toxicity in patients who took
DURACT for periods of time beyond
that recommended in the labeling.
In a letter dated December 9, 2011,
Wyeth requested that FDA withdraw
approval of NDA 20–535, DURACT
(bromfenac sodium) Capsules, under
§ 314.150(d) (21 CFR 314.150(d)). In that
letter, Wyeth also waived its
opportunity for a hearing, provided
under § 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), and under authority
delegated by the Commissioner of Food
and Drugs to the Director, Center for
Drug Evaluation and Research, approval
of NDA 20–535, 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: June 21, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2012–16597 Filed 7–6–12; 8:45 am]
Wyeth Pharmaceuticals, Inc.;
Withdrawal of Approval of a New Drug
Application for DURACT Capsules
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for DURACT (bromfenac sodium)
Capsules, held by Wyeth
Pharmaceuticals, Inc. (Wyeth), P.O. Box
8299, Philadelphia, PA 19101–8299.
Wyeth, now a part of Pfizer, Inc., has
voluntarily requested that approval of
this application be withdrawn, thereby
waiving its opportunity for a hearing.
DATES: Effective July 9, 2012.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice.
SUMMARY:
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[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Page 40367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0690]
Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug
Application for DURACT Capsules
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules,
held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299,
Philadelphia, PA 19101-8299. Wyeth, now a part of Pfizer, Inc., has
voluntarily requested that approval of this application be withdrawn,
thereby waiving its opportunity for a hearing.
DATES: Effective July 9, 2012.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In June 1998, Wyeth voluntarily withdrew
DURACT (bromfenac sodium) Capsules from the market. DURACT (bromfenac
sodium) Capsules, a nonsteroidal anti-inflammatory drug indicated for
the short-term management of acute and chronic pain, were withdrawn
from the market after FDA and Wyeth received postmarketing reports of
rare, severe liver toxicity in patients who took DURACT for periods of
time beyond that recommended in the labeling.
In a letter dated December 9, 2011, Wyeth requested that FDA
withdraw approval of NDA 20-535, DURACT (bromfenac sodium) Capsules,
under Sec. 314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also
waived its opportunity for a hearing, 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 NDA 20-
535, 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: June 21, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-16597 Filed 7-6-12; 8:45 am]
BILLING CODE 4160-01-P
