[Federal Register Volume 65, Number 69 (Monday, April 10, 2000)]
[Notices]
[Page 18998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P-4848]


Determination That Carbinoxamine Maleate 4 Milligrams per 5 Cubic 
Centimeters Elixir Was Not Withdrawn From Sale for Reasons of Safety or 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 
carbinoxamine maleate (Clistin) 4 milligrams (mg) per 5 cubic 
centimeters (cc) elixir was not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDA's) for carbinoxamine maleate 4 
mg per 5 cc elixir.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, 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 
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 ANDA's 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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic 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,'' 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Under FDA regulations, drugs are withdrawn from the list if the agency 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 Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)) 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. FDA may not approve an ANDA 
that does not refer to a listed drug.
    In a citizen petition dated October 8, 1999 (Docket No. 99P-4848/
CP1), submitted under 21 CFR 314.122, Mikart, Inc., requested that the 
agency determine whether carbinoxamine maleate (Clistin) 4 mg per 5 cc 
elixir was withdrawn from sale for reasons of safety or effectiveness. 
Carbinoxamine maleate (Clistin) 4 mg per 5 cc elixir was the subject of 
approved NDA 8-955. In the Federal Register of April 5, 1985 (50 FR 
13661), FDA withdrew approval of NDA 8-955 for Clistin Elixir after 
McNeil Pharmaceutical notified the agency that Clistin Elixir was no 
longer being marketed under NDA 8-955 and requested the withdrawal of 
that application.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that carbinoxamine maleate 4 mg per 5 cc elixir was not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will list carbinoxamine maleate 4 mg per 5 cc 
elixir in the ``Discontinued Drug Product List'' section of the Orange 
Book. The ``Discontinued Drug Product List'' identifies, among other 
items, drug products that have been discontinued from marketing for 
reasons other than safety or effectiveness. ANDA's that refer to 
carbinoxamine maleate 4 mg per 5 cc elixir as the listed drug may be 
approved by the agency.

    Dated: April 3, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-8715 Filed 4-7-00; 8:45 am]
BILLING CODE 4160-01-F