Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application, 32852 [E7-11427]
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32852
Federal Register / Vol. 72, No. 114 / Thursday, June 14, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Request for reconsideration of a
decision
5
1 time for each
application
5
2
10
Request for review—(user fee appeal officer)
2
1 time for each
application
2
2
4
Total
60
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2003.
FDA’s Center for Veterinary Medicine
estimates 30 waiver requests that
include the following: 5 significant
barriers to innovation, 1 fee exceed cost,
5 free choice feeds, 10 minor use or
minor species, 2 small business waiver
requests, 5 requests for reconsideration
of a decision, and 2 requests for user fee
appeal officer. The estimated hours per
response are based on past FDA
experience with the various waiver
requests in FDA’s Center for Drug
Evaluation and Research. The hours per
response are based on the average of
these estimates.
Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11425 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0221]
Otsuka Pharmaceutical Co., Ltd.;
Withdrawal of Approval of a New Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for RAXAR (grepafloxacin
hydrochloride (HCl)) Tablets held by
Otsuka Pharmaceutical Co., Ltd.
(Otsuka), c/o Otsuka Pharmaceutical
Development & Commercialization, Inc.,
VerDate Aug<31>2005
17:22 Jun 13, 2007
Jkt 211001
2440 Research Blvd., Rockville, MD
20850. Otsuka has voluntarily requested
that approval of this application be
withdrawn because the product is no
longer marketed, thereby waiving its
opportunity for a hearing.
DATES: Effective June 14, 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 a letter
dated March 5, 2003, Otsuka requested
that FDA withdraw approval of NDA
20–695 for RAXAR (grepafloxacin HC1)
Tablets, stating that the product was no
longer being marketed. In FDA’s
acknowledgment letter of June 20, 2003,
the agency informed Otsuka that
RAXAR (grepafloxacin HCl) Tablets,
indicated for the treatment of a variety
of infections, had been removed from
the market because of safety concerns;
in its follow-up letter of January 12,
2007, the agency also informed Otsuka
that it had determined that the RAXAR
NDA should be withdrawn under
§ 314.150(d) (21 CFR 314.150(d))
because of its effect on cardiac
repolarization, manifested as QTc
interval prolongation on the
electrocardiogram, which could put
patients at risk of Torsade de Pointes. In
its letter of March 20, 2007, Otsuka
concurred in the agency’s determination
to initiate withdrawal of the RAXAR
NDA and waived its opportunity for a
hearing, provided under 21 CFR
314.150(a) and (b).
Therefore, under section 505(e) of the
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 (21 CFR 5.105(a)), approval of
the NDA 20–695, and all amendments
and supplements thereto, is withdrawn,
effective (see DATES). Distribution of this
product in interstate commerce without
an approved application is illegal and
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
subject to regulatory action (see sections
505(a) and 301(d) of the act (21 U.S.C.
331(d)).
Dated: May 31, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–11427 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 24, 2007, from 8 a.m. to 5
p.m.
Location: Advisors and Consultants
Staff Conference Room, 5630 Fishers
Lane, rm. 1066, Rockville, MD 20857.
Contact Person: Johanna Clifford,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
6761, FAX: 301–827–6776, e-mail:
Johanna.Clifford@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 72, Number 114 (Thursday, June 14, 2007)]
[Notices]
[Page 32852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11427]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0221]
Otsuka Pharmaceutical Co., Ltd.; 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 RAXAR (grepafloxacin hydrochloride
(HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o
Otsuka Pharmaceutical Development & Commercialization, Inc., 2440
Research Blvd., Rockville, MD 20850. Otsuka has voluntarily requested
that approval of this application be withdrawn because the product is
no longer marketed, thereby waiving its opportunity for a hearing.
DATES: Effective June 14, 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 a letter dated March 5, 2003, Otsuka
requested that FDA withdraw approval of NDA 20-695 for RAXAR
(grepafloxacin HC1) Tablets, stating that the product was no longer
being marketed. In FDA's acknowledgment letter of June 20, 2003, the
agency informed Otsuka that RAXAR (grepafloxacin HCl) Tablets,
indicated for the treatment of a variety of infections, had been
removed from the market because of safety concerns; in its follow-up
letter of January 12, 2007, the agency also informed Otsuka that it had
determined that the RAXAR NDA should be withdrawn under Sec.
314.150(d) (21 CFR 314.150(d)) because of its effect on cardiac
repolarization, manifested as QTc interval prolongation on the
electrocardiogram, which could put patients at risk of Torsade de
Pointes. In its letter of March 20, 2007, Otsuka concurred in the
agency's determination to initiate withdrawal of the RAXAR NDA and
waived its opportunity for a hearing, provided under 21 CFR 314.150(a)
and (b).
Therefore, under section 505(e) of the 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 (21 CFR 5.105(a)), approval of the NDA 20-695, and all
amendments and supplements thereto, is withdrawn, effective (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 act (21 U.S.C. 331(d)).
Dated: May 31, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-11427 Filed 6-13-07; 8:45 am]
BILLING CODE 4160-01-S
