[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Notices]
[Pages 7114-7115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4287]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94P-0206]


Determination that Evans Blue Dye Injection Was Not Withdrawn 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 
Evans Blue Dye Injection, an approved new drug application (NDA) held 
by Parke-Davis & Co., a division of Warner-Lambert Co., was not 
withdrawn from sale for reasons of safety or effectiveness and is 
relisting the drug in its publication entitled ``Approved Drug Products 
with Therapeutic Equivalence Evaluations.'' This will allow sponsors to 
submit abbreviated new drug applications (ANDA's) for Evans Blue Dye 
Injection.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION: In 1984, Congress passed into law the Drug 
Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-
417) (the 1984 amendments), which authorized the approval of duplicate 
versions of drug products 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 an NDA. Sponsors of ANDA's 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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(6)), 
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 Under FDA regulations, drugs are withdrawn from the 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 (Sec. 314.162 (21 CFR 314.162)). Regulations also provide 
that the agency must make a determination as to 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 
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an 
ANDA that does not refer to a listed drug.
    On June 6, 1994, the New World Trading Corp. submitted a citizen 
petition (Docket No. 94P-0206/CP1) under 21 CFR 10.25(a) and 10.30 
requesting that the agency determine whether Evans Blue Dye Injection 
was withdrawn from sale for reasons of safety or effectiveness and, if 
the agency determines that the drug was not withdrawn from sale for 
reasons of safety or effectiveness, to relist the drug in the 
``Approved Drug Products with Therapeutic Equivalence Evaluations.'' 
Evans Blue Dye Injection was the subject of approved NDA 8-041 held by 
Parke-Davis & Co., a division of Warner Lambert Co. Evans Blue Dye 
Injection was withdrawn from sale in June 1978, and the NDA was 
withdrawn, with the consent of the sponsor, in a notice 

[[Page 7115]]
published in the Federal Register of November 15, 1990 (55 FR 47807).
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that Evans Blue Dye Injection was not 
withdrawn from sale for reasons of safety or effectiveness and will 
relist Evans Blue Dye Injection in the ``Discontinued Drug Product 
List'' contained in the ``Approved Drug Products with Therapeutic 
Equivalence Evaluations.'' The ``Discontinued Drug Product List'' 
lists, among other items, drug products that have had their approvals 
withdrawn for reasons other than safety and efficacy subsequent to 
being discontinued from marketing. ANDA's that refer to Evans Blue Dye 
Injection may be submitted to the agency.

    Dated: February 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4287 Filed 2-23-96; 8:45 am]
BILLING CODE 4160-01-F