[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Notices]
[Pages 48918-48919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01P-0533]


Determination That Cyanocobalamin Injection Was Not Withdrawn 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 
cyanocobalamin injection (Rubramin PC), 1 milligram (mg)/milliliter 
(mL) in a 10 mL vial (cyanocobalamin injection) was not withdrawn from 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 
cyanocobalamin injection.

FOR FURTHER INFORMATION CONTACT: J. Kenneth Borgerding, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price

[[Page 48919]]

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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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 (21 CFR 314.161(a)(1)). FDA may not approve an ANDA 
that does not refer to a listed drug.
    Cyanocobalamin injection (Rubramin PC), 1mg/mL in a 10 mL vial is 
the subject of NDA 6-799. On November 28, 1951, Bristol-Myers Squibb 
Co. received approval to market cyanocobalamin injection. 
Cyanocobalamin is vitamin B12. Subsequently, Bristol-Meyers 
Squibb Co. withdrew cyanocobalamin injection from sale.
    On November 29, 2001, PharmaForce, Inc., submitted a citizen 
petition (Docket No. 01P-0533) under 21 CFR 10.30 to FDA requesting 
that the agency determine whether cyanocobalamin injection was 
withdrawn from sale for reasons of safety or effectiveness. FDA has 
reviewed its records and determined that cyanocobalamin injection was 
not withdrawn from the market for safety or efficacy reasons. 
Accordingly, the agency will list cyanocobalamin 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 cyanocobalamin 
injection may be approved by the agency.

    Dated: July 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18976 Filed 7-25-02; 8:45 am]
BILLING CODE 4160-01-S