[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Page 37244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13160]


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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.

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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determined that the RAXAR NDA should be withdrawn under Sec.  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