[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Page 36611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-2559]


Determination That FORTAMET (Metformin Hydrochloride) Extended-
Release Tablets, 500 Milligrams and 1 Gram, Were Not Withdrawn From 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 or Agency) has 
determined that FORTAMET (metformin hydrochloride) extended-release 
tablets, 500 milligrams (mg) and 1 gram (g), were not withdrawn from 
sale for reasons of safety or effectiveness. This determination means 
that FDA will not begin procedures to withdraw approval of abbreviated 
new drug applications (ANDAs) that refer to these drug products, and it 
will allow FDA to continue to approve ANDAs that refer to these 
products as long as they meet relevant legal and regulatory 
requirements.

FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3702, [email protected].

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 under an ANDA procedure. ANDA applicants 
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. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    FORTAMET (metformin hydrochloride) extended-release tablets, 500 mg 
and 1 g, are the subject of NDA 021574, held by Andrx Labs, LLC, and 
initially approved on April 27, 2004. FORTAMET is indicated as an 
adjunct to diet and exercise to improve glycemic control in adults with 
type 2 diabetes mellitus.
    FORTAMET (metformin hydrochloride) extended-release tablets, 500 mg 
and 1 g, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book. Ajanta Pharma Limited submitted a citizen 
petition dated May 27, 2019 (Docket No. FDA-2019-P-2559), under 21 CFR 
10.30, requesting that the Agency determine whether FORTAMET (metformin 
hydrochloride) extended-release tablets, 500 mg and 1 g, were withdrawn 
from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that FORTAMET (metformin hydrochloride) extended-
release tablets, 500 mg and 1 g, were not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that FORTAMET (metformin hydrochloride) 
extended-release tablets, 500 mg and 1 g, were withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of FORTAMET (metformin hydrochloride) 
extended-release tablets, 500 mg and 1 g, from sale. We have also 
independently evaluated relevant literature and data for possible post 
marketing adverse events. We have reviewed the available evidence and 
determined that these drug products were not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list FORTAMET (metformin 
hydrochloride) extended-release tablets, 500 mg and 1 g, 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. FDA will not begin procedures to withdraw 
approval of approved ANDAs that refer to this drug product. Additional 
ANDAs for this drug product may also be approved by the Agency as long 
as they meet all other legal and regulatory requirements for the 
approval of ANDAs. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16008 Filed 7-26-19; 8:45 am]
 BILLING CODE 4164-01-P