[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Notices]
[Pages 27986-27987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0062]


Determination That Carbinoxamine Maleate 4-Milligram Immediate-
Release Tablets Were Not Withdrawn From Sale for Reasons of Safety or 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<Register>) 4-milligram (mg) immediate-
release tablets were not withdrawn from sale for reasons of safety or 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 
immediate-release tablets.

FOR FURTHER INFORMATION CONTACT: Richard L. Schwartzbard, 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 (Pub. L. 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 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 (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 Under FDA regulations, drugs are withdrawn from the list if the 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 (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.
    In a citizen petition dated January 22, 1998 (Docket No. 98P-0062/
CP1), submitted in accordance with 21 CFR 314.122, Sage Pharmaceuticals 
requested that the agency determine whether carbinoxamine maleate 
(Clistin<Register>) 4-mg immediate-release tablets were withdrawn from 
sale for reasons of safety or effectiveness. Carbinoxamine maleate 
(Clistin<Register>) 4-mg immediate-release tablets were the subject of 
approved NDA 8-915.\1\ On

[[Page 27987]]

January 26, 1993, the R. W. Johnson Pharmaceutical Research Institute 
notified FDA in writing that carbinoxamine maleate (Clistin<Register>) 
4-mg immediate-release tablets were no longer being marketed under NDA 
8-915 and requested the withdrawal of that application. FDA complied 
and announced the withdrawal of approval for NDA 8-915 in the Federal 
Register of March 2, 1994 (59 FR 9989).
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    \1\ NDA 8-915 also covered Clistin<Register> R-A, a controlled-
release form of carbinoxamine maleate tablets. In the Federal 
Register of July 29, 1983 (48 FR 34514), FDA withdrew approval of 
NDA 8-915 as it pertained to Clistine<Register> R-A because no 
person submitted bioavailability data showing that the product was 
effective as a controlled-release dosage form.
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    FDA has reviewed its records and, under Sec. 314.161, has 
determined that carbinoxamine maleate 4-mg immediate-release tablets 
were not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will maintain carbinoxamine maleate 4-mg 
immediate-release tablets 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 
immediate-release tablets may be approved by the agency.

    Dated: May 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13468 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F