E7-13160. 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letter of January 12, 2007, the agency also informed Otsuka that it had determined that the RAXAR NDA should be withdrawn under § 314.150(d) (21 CFR 314.150(d)) because of its effect on cardiac repolarization, manifested as QTc interval prolongation on the electrocardiogram, which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.