[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Notices]
[Pages 65968-65969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006P-0291, 2006P-0299, 2006P-0298, 2006P-0309, and 2007P-
0062]


Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 
100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was 
Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per 
vial, sterile lyophilized powder for injection, was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/
vial.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers

[[Page 65969]]

Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    Under 21 CFR 314.161(a)(1), the agency must determine whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    ELOXATIN (oxaliplatin for injection), 50 and 100 mg/vial, sterile 
lyophilized powder for injection, is the subject of approved NDA 21-492 
held by Sanofi-Aventis. Oxaliplatin sterile lyophilized powder for 
injection, 50 and 100 mg/vial, is a chemotherapeutic agent indicated 
for adjuvant treatment of stage III colon cancer patients who have 
undergone complete resection of the primary tumor. Sanofi-Aventis 
ceased manufacturing ELOXATIN (oxaliplatin for injection), 50 and 100 
mg/vial, sterile lyophilized powder for injection, in June 2006.
    FDA received five citizen petitions, submitted under 21 CFR 10.30, 
requesting that the agency determine whether oxaliplatin sterile 
lyophilized powder for injection, 50 and 100 mg/vial, was withdrawn 
from sale for reasons of safety or effectiveness. The petitions were 
submitted as follows:
     Sicor Pharmaceuticals, Inc., submitted a citizen petition 
dated July 24, 2006 (Docket No. 2006P-0291/CP1).
     Rothwell, Figg, Ernst & Manbeck, P.C., submitted a citizen 
petition dated July 24, 2006 (Docket No. 2006P-0299/CP1).
     AAC Consulting Group submitted a citizen petition dated 
July 25, 2006 (Docket No. 2006P-0298/CP1).
     Frommer Lawrence & Haug LLP submitted a citizen petition 
dated August 4, 2006 (Docket No. 2006P-0309/CP1).
     Regulus Pharmaceutical Consulting, Inc., submitted a 
citizen petition dated February 20, 2007 (Docket No. 2007P-0062/CP1).
    The agency has determined that ELOXATIN (oxaliplatin for 
injection), 50 and 100 mg/vial, sterile lyophilized powder for 
injection, was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioners have identified no data or other 
information suggesting that oxaliplatin sterile lyophilized powder for 
injection, 50 and 100 mg/vial, was withdrawn from sale as a result of 
safety or effectiveness concerns. FDA's independent evaluation of 
relevant information has uncovered no information that would indicate 
this product was withdrawn for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing agency 
records, FDA determines that for the reasons outlined previously, 
ELOXATIN (oxaliplatin for injection), 50 and 100 mg/vial, sterile 
lyophilized powder for injection, was not withdrawn from sale for 
reasons of safety or effectiveness. Accordingly, the agency will 
continue to list ELOXATIN (oxaliplatin for injection), 50 and 100 mg/
vial, sterile lyophilized powder for injection, in the ``Discontinued 
Drug Product List'' section of the Orange Book. The ``Discontinued Drug 
Product List'' delineates, among other items, drug products that have 
been discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to ELOXATIN (oxaliplatin for 
injection), 50 and 100 mg/vial, sterile lyophilized powder for 
injection, may be approved by the agency as long as they meet all 
relevant legal and regulatory requirements for the approval of ANDAs. 
If FDA determines that the labeling of this drug product should be 
revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: November 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22973 Filed 11-23-07; 8:45 am]
BILLING CODE 4160-01-S