[Federal Register Volume 72, Number 114 (Thursday, June 14, 2007)]
[Notices]
[Page 32852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11427]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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that approval of this application be withdrawn because the product is 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determined that the RAXAR NDA should be withdrawn under Sec.  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]
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