[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33100-33101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15442]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-1496]


Determination That Metformin Hydrochloride Tablets, 625 and 750 
Milligrams Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that 
metformin hydrochloride (HCl) tablets (Glucophage), 625 and 750 
milligrams (mg), were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for metformin HCl 625- and 750-mg 
tablets.

FOR FURTHER INFORMATION CONTACT: Paul C. Varki, 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 (the 1984 
amendments) (Public Law 98-417), 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,'' 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Under FDA regulations, drugs are withdrawn from the list if the agency 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.
    Metformin HCl 625- and 750-mg tablets are the subject of NDA 20-
357. When first approved, the NDA provided for 500- and 850-mg tablets. 
On July 8, 1998, Bristol-Myers Squibb Co. submitted a supplemental NDA 
to market the 625-, 750-, and 1000-mg tablets. FDA approved this 
supplement on November 5, 1998. On November 11, 1998, Bristol-Myers 
Squibb notified FDA that it would not market the 750-mg strength 
tablet. The 625-mg strength tablet has not been marketed either.
    On August 31, 2000, Lachman Consultant Services, Inc., submitted a 
citizen petition (Docket No. 00P-1496/

[[Page 33101]]

CP1) under 21 CFR 10.30 to FDA. The petition requested that the agency 
determine whether metformin HCl tablets, 625- and 750-mg were withdrawn 
from sale for reasons of safety or effectiveness.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Bristol-Myers Squibb's decision not to market metformin 
HCl 625- and 750-mg tablets was not due to concerns about safety or 
effectiveness of the product. Accordingly, the agency will maintain 
metformin HCl 625- and 750-mg tablets 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 metformin HCl 
625- and 750-mg tablets may be approved by the agency.

    Dated: June 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15442 Filed 6-19-01; 8:45 am]
BILLING CODE 4160-01-S