[Federal Register: March 8, 2004 (Volume 69, Number 45)]
[Notices]               
[Page 10711-10712]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr04-69]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003P-0266]

 
Determination That LOVENOX (Enoxaparin Sodium) 90 Milligrams/0.6 
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or 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) is announcing its 
determination that LOVENOX (enoxaparin sodium) 90 milligrams (mg)/0.6 
milliliter (mL) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for enoxaparin sodium 90 mg/0.6 mL.

FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers 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 under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 Under FDA regulations, drugs are withdrawn from the list if the 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

[[Page 10712]]

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 Sec.  314.161(a)(1) (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.
    LOVENOX (enoxaparin sodium) 90 mg/0.6 mL, is the subject of 
approved NDA 20-164 held by Aventis Pharmaceuticals, Inc. (Aventis). 
LOVENOX (enoxaparin sodium) 90 mg/0.6 mL, approved June 2, 2000, is an 
anticoagulant indicated for the prophylaxis of deep vein thrombosis, 
which may lead to pulmonary embolism. Aventis never marketed the 90mg/
0.6 mL presentation of LOVENOX. On June 10, 2003, Olsson, Frank and 
Weeda, P.C. submitted a citizen petition (Docket No. 2003P-0266) under 
Sec.  314.161 and 21 CFR 10.21(a) and 10.30, requesting that the agency 
determine whether LOVENOX (enoxaparin sodium) 90 mg/0.6 mL was 
withdrawn from sale for reasons of safety or effectiveness. The agency 
has determined that, for purposes of Sec.  314.161(a) and (c), never 
marketing an approved drug product is equivalent to withdrawing the 
drug from sale.
    The agency has determined that Aventis' LOVENOX (enoxaparin sodium) 
90 mg/0.6 mL was not withdrawn from sale for reasons of safety or 
effectiveness. In support of this finding, we note that Aventis 
continues to market other presentations of LOVENOX that are the same 
concentration as LOVENOX 90 mg/0.6 mL. FDA has independently evaluated 
relevant literature and data for adverse event reports and has found no 
information that would indicate this product was withdrawn for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined previously, Aventis' 
LOVENOX (enoxaparin sodium) 90 mg/0.6 mL was not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list LOVENOX (enoxaparin sodium) 90 mg/0.6 mL 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 LOVENOX (enoxaparin 
sodium) 90 mg/0.6 mL may be approved by the agency.

    Dated: February 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5106 Filed 3-5-04; 8:45 am]

BILLING CODE 4160-01-S