Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application; Correction, 37244 [E7-13160]
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37244
Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices
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SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379e(d)(1)), notice is given
that a color additive petition (CAP
7C0283) has been filed by Nippon Oil
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66210. The petition proposes to amend
the color additive regulations in 21 CFR
part 73 to provide for the safe use of
Paracoccus carotinifaciens granules as a
color additive in the feed of salmonid
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The agency has determined under 21
CFR 25.32(r) that this action is of a type
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the human environment. Therefore,
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nor an environmental impact statement
is required.
Dated: June 28, 2007.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E7–13161 Filed 7–6–07; 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; Correction
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 14, 2007 (72 FR 32852).
The agency issued a withdrawal 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. The
document published with typographical
errors and cited a section of the Code of
Federal Regulations that no longer
exists. This document corrects those
errors. The agency is also announcing
the removal of RAXAR Tablets from the
list of approved drug products in FDA’s
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
(the Orange Book).
DATES: Effective July 9, 2007.
VerDate Aug<31>2005
16:59 Jul 06, 2007
Jkt 211001
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
In FR Doc.
E7–11427, appearing on page 32852 in
the Federal Register of Thursday, June
14, 2007, the following correction is
made:
1. On page 32852, in the second and
third columns, the SUPPLEMENTARY
INFORMATION section is corrected to read:
SUPPLEMENTARY INFORMATION: In a
letter dated March 5, 2003, Otsuka
requested that FDA withdraw approval
of NDA 20–695 for RAXAR
(grepafloxacin HCl) 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
followup 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 § 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, by the Commissioner of Food
and Drugs, 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)). Also, on the basis of the
circumstances described in this
document that led to the withdrawal of
the approval of NDA 20–695, the agency
will remove RAXAR (grepafloxacin HCl)
Tablets from the list of drug products
with effective approvals published in
the Orange Book.
Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–13160 Filed 7–6–07; 8:45 am]
BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00063
Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0524]
Guidance for Industry on ANDAs:
Pharmaceutical Solid Polymorphism;
Chemistry, Manufacturing, and
Controls Information; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘ANDAs: Pharmaceutical Solid
Polymorphism; Chemistry,
Manufacturing, and Controls
Information.’’ The guidance is intended
to assist applicants with the submission
of abbreviated new drug applications
(ANDAs) when a drug substance exists
in polymorphic forms.
DATES: Submit written or electronic
comments on agency guidance
documents at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Andre Raw, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9310.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘ANDAs: Pharmaceutical Solid
Polymorphism; Chemistry,
Manufacturing, and Controls
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Page 37244]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13160]
-----------------------------------------------------------------------
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; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of June 14, 2007 (72 FR 32852).
The agency issued a withdrawal 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. The document published with typographical errors and cited a
section of the Code of Federal Regulations that no longer exists. This
document corrects those errors. The agency is also announcing the
removal of RAXAR Tablets from the list of approved drug products in
FDA's ``Approved Drug Products With Therapeutic Equivalence
Evaluations'' (the Orange Book).
DATES: Effective July 9, 2007.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: In FR Doc. E7-11427, appearing on page 32852
in the Federal Register of Thursday, June 14, 2007, the following
correction is made:
1. On page 32852, in the second and third columns, the
SUPPLEMENTARY INFORMATION section is corrected to read:
SUPPLEMENTARY INFORMATION: In a letter dated March 5, 2003, Otsuka
requested that FDA withdraw approval of NDA 20-695 for RAXAR
(grepafloxacin HCl) 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 followup
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 Sec. 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, by the Commissioner of Food and Drugs, 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)). Also, on the basis of the circumstances described in this
document that led to the withdrawal of the approval of NDA 20-695, the
agency will remove RAXAR (grepafloxacin HCl) Tablets from the list of
drug products with effective approvals published in the Orange Book.
Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13160 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S
