Document ID: FDA-2012-N-0376-0001
Agency: fda
Document Type: Notice
Title: Sanofi-aventis, U.S., LLC; Withdrawal of Approval of New Drug Applications for OFORTA
Posted Date: 2012-04-25T04:00Z

[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Page 24724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0376]

Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug 
Application for OFORTA

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 OFORTA (fludarabine phosphate) 
Tablets held by sanofi-aventis, U.S., LLC (sanofi-aventis), 55 
Corporate Dr., Bridgewater, NJ 08807-0977. Sanofi-aventis has 
voluntarily requested that approval of this application be withdrawn, 
thereby waiving its opportunity for a hearing.

DATES: Effective December 31, 2011.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA approved OFORTA (fludarabine phosphate) 
Tablets on December 18, 2008, under the Agency's accelerated approval 
regulations, 21 CFR part 314, subpart H. OFORTA is approved for use as 
a single agent for the treatment of adult patients with B-cell chronic 
lymphocytic leukemia whose disease has not responded to or has 
progressed during or after treatment with at least one standard 
alkylating agent-containing regimen. On February 10, 2011, FDA 
requested that sanofi-aventis voluntarily withdraw OFORTA (fludarabine 
phosphate) Tablets from the market, because the postmarketing study 
required as a condition of approval under subpart H had not been 
completed and clinical benefit had not been verified. In a letter dated 
June 24, 2011, sanofi-aventis requested that FDA withdraw approval of 
NDA 22-273 for OFORTA (fludarabine phosphate) Tablets under Sec.  
314.150(d), noting the lack of commercial demand for OFORTA and 
significant challenges to completing the postmarketing study. In that 
letter, sanofi-aventis also waived its opportunity for a hearing, 
otherwise provided under Sec. Sec.  314.150 and 314.530. In a letter 
dated July 8, 2011, the Agency acknowledged sanofi-aventis' agreement 
to permit FDA to withdraw approval of OFORTA under Sec.  314.150(d) and 
waive its opportunity for a hearing. The Agency noted that the required 
postmarketing study had not been completed and clinical benefit had not 
been verified.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and 
under authority delegated by the Commissioner to the Director, Center 
for Drug Evaluation and Research, approval of NDA 22-273, and all 
amendments and supplements thereto, is withdrawn (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 FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: April 5, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-9943 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-01-P