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[Federal Register: May 23, 2002 (Volume 67, Number 100)]
[Notices]               
[Page 36197-36198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my02-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01P-0447]

 
Determination That Ardeparin Sodium Injection Was Not Withdrawn 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 
ardeparin sodium injection (Normiflo) was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for ardeparin 
sodium injection.

FOR FURTHER INFORMATION CONTACT: David Read, Center for Drug Evaluation 
and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5605.

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 Under FDA regulations, drugs are withdrawn from the list if the 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 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 <l-arrow> 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.
    Ardeparin sodium injection (Normiflo) was the subject of approved 
NDA 20-227, formerly held by Wyeth-Ayerst and then by Pharmacia & 
Upjohn. Normiflo is a low molecular weight heparin indicated for the 
prevention of deep vein thrombosis which may lead to pulmonary embolism 
following knee replacement surgery. FDA received a request from 
Pharmacia & Upjohn, dated May 22, 2001, to withdraw approval of NDA 20-
227 for Normiflo injection in accordance with 21 CFR 314.150(c). 
Following Pharmacia & Upjohn's request, Normiflo was moved from the 
prescription drug product list to the ``Discontinued Drug Product 
List'' section of the Orange Book. Approval of the application was 
withdrawn on February 11, 2002 (67 FR 6264).
    In a citizen petition dated September 19, 2001 (Docket No. 01P-
0447/CP1), submitted under 21 CFR 10.30, John W. Herr requested that 
the agency determine whether ardeparin sodium injection was withdrawn 
from sale for reasons of safety or effectiveness.
    The agency has determined that Normiflo was not withdrawn from sale 
for reasons of safety or effectiveness. The petitioner identified no 
data or other information suggesting that Normiflo was withdrawn from 
sale as a result of safety or effectiveness concerns. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse event reports, but 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 in this notice, ardeparin 
sodium injection approved under NDA 20-227 was not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list Normiflo (ardeparin sodium 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 Normiflo (ardeparin 
sodium

[[Page 36198]]

injection) may be approved by the agency.

    Dated: May 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12874 Filed 5-22-02; 8:45 am]
BILLING CODE 4160-01-S

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