Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application, 4270 [E7-1414]
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Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices
ycherry on PROD1PC64 with NOTICES
descriptions of positions (see 21 CFR
12.24(b)(2)). Although FDA’s proposal
to debar Mr. Kimball explained that he
had the opportunity to file a request for
a hearing and then submit factual
information within 60 days from receipt
of the letter, Mr. Kimball did not submit
any factual information. Mr. Kimball
has failed to present any arguments or
information to show why he should not
be debarred. Therefore, FDA finds that
Mr. Kimball has failed to identify any
genuine and substantial issue of fact
requiring a hearing. Accordingly, FDA
denies Mr. Kimball’s request for a
hearing.
III. Findings and Order
Therefore, the Associate
Commissioner for Regulatory Affairs,
under section 306(a) of the act and
under authority delegated to him, finds
that Mr. James T. Kimball has been
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the act (section
306(a)(2)(B) of the act).
As a result of the foregoing findings,
Mr. James T. Kimball is permanently
debarred 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
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) (sections 306(c)(1)(B) and
(c)(2)(A)(iii) and 201(dd) of the act (21
U.S.C. 321(dd))). Any person with an
approved or pending drug product
application who knowingly uses the
services of Mr. Kimball in any capacity,
during his period of debarment, will be
subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C.
335b(a)(6))). If Mr. Kimball, during his
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, he will be subject to civil
money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
assistance of Mr. Kimball during his
period of debarment.
Any application by Mr. Kimball for
termination of debarment under section
306(d)(4) of the act should be identified
with Docket No. 2005N–0105 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.
VerDate Aug<31>2005
15:36 Jan 29, 2007
Jkt 211001
Dated: January 22, 2007.
Margaret O’K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. E7–1416 Filed 1–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0029]
Indevus Pharmaceuticals, Inc.;
Withdrawal of Approval of a New Drug
Application
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 REDUX (dexfenfluramine
hydrochloride (HCl)) Capsules held by
Indevus Pharmaceuticals, Inc. (Indevus),
33 Hayden Ave., Lexington, MA 02421–
7971. Indevus has requested that
approval of this application be
withdrawn because the product is no
longer marketed, thereby waiving its
opportunity for a hearing.
DATES: Effective January 30, 2007.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
In 1997,
FDA asked that REDUX
(dexfenfluramine HCl) be withdrawn
from the market because of safety
concerns; Indevus (formerly Interneuron
Pharmaceuticals, Inc.) discontinued
marketing this product. REDUX
(dexfenfluramine HCl)Capsules, a
treatment for obesity, was withdrawn
from the market after review of safety
data showed that the product is
associated with valvular heart disease
(see FDA press releases on ‘‘Health
Advisory on Fenfluramine/Phentermine
for Obesity,’’ dated July 8, 1997, (https://
www.fda.gov/opacom/hpnews.html),
and ‘‘FDA Announces Withdrawal of
Fenfluramine and Dexfenfluramine,’’
dated September 15, 1997, (https://
www.fda.gov/opacom/hpnews.html)).
In a letter dated January 16, 2006,
Indevus requested that FDA withdraw
approval, under § 314.150(d) (21 CFR
314.150(d)), of NDA 20–344 for REDUX
(dexfenfluramine HCl) Capsules, stating
that it had discontinued marketing the
product. The letter also stated that
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Frm 00040
Fmt 4703
Sfmt 4703
Indevus believes that the risk/benefit
ratio for the use of dexfenfluramine is
unfavorable and that withdrawal of
approval of NDA 20–344 is in the best
interest of public health. Indevus
voluntarily waived its opportunity for a
hearing, provided under § 314.150(a)
and (b).
Therefore, under section 505(e) of
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(e)), § 314.150(d),
and under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of NDA 20–544,
and all amendments and supplements
thereto, is withdrawn, effective January
30, 2007. 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 act (21 U.S.C.
331(d)).
Dated: January 12, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–1414 Filed 1–29–07; 8:45 am]
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[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Page 4270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1414]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0029]
Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New
Drug Application
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 REDUX (dexfenfluramine
hydrochloride (HCl)) Capsules held by Indevus Pharmaceuticals, Inc.
(Indevus), 33 Hayden Ave., Lexington, MA 02421-7971. Indevus has
requested that approval of this application be withdrawn because the
product is no longer marketed, thereby waiving its opportunity for a
hearing.
DATES: Effective January 30, 2007.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In 1997, FDA asked that REDUX
(dexfenfluramine HCl) be withdrawn from the market because of safety
concerns; Indevus (formerly Interneuron Pharmaceuticals, Inc.)
discontinued marketing this product. REDUX (dexfenfluramine
HCl)Capsules, a treatment for obesity, was withdrawn from the market
after review of safety data showed that the product is associated with
valvular heart disease (see FDA press releases on ``Health Advisory on
Fenfluramine/Phentermine for Obesity,'' dated July 8, 1997, (https://
www.fda.gov/opacom/hpnews.html), and ``FDA Announces Withdrawal of
Fenfluramine and Dexfenfluramine,'' dated September 15, 1997, (https://
www.fda.gov/opacom/hpnews.html)).
In a letter dated January 16, 2006, Indevus requested that FDA
withdraw approval, under Sec. 314.150(d) (21 CFR 314.150(d)), of NDA
20-344 for REDUX (dexfenfluramine HCl) Capsules, stating that it had
discontinued marketing the product. The letter also stated that Indevus
believes that the risk/benefit ratio for the use of dexfenfluramine is
unfavorable and that withdrawal of approval of NDA 20-344 is in the
best interest of public health. Indevus voluntarily waived its
opportunity for a hearing, provided under Sec. 314.150(a) and (b).
Therefore, under section 505(e) of Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355(e)), Sec. 314.150(d), and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner of Food and Drugs, approval of NDA 20-544, and all
amendments and supplements thereto, is withdrawn, effective January 30,
2007. 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 act (21 U.S.C. 331(d)).
Dated: January 12, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-1414 Filed 1-29-07; 8:45 am]
BILLING CODE 4160-01-S