[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72366-72367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28270]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-3877]
Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral
Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR
(Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams
and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety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, Agency, or we) has
determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500
milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, 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not withdrawn from sale for reasons of safety or effectiveness.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
[[Page 72367]]
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.
GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg,
and 1 g, are the subject of NDA 020357, held by EMD Serono Inc. and
initially approved on March 3, 1995. GLUCOPHAGE is indicated as an
adjunct to diet and exercise to improve glycemic control in adults and
pediatric patients 10 years of age and older with type 2 diabetes
mellitus. GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg,
850 mg, and 1 g, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
GLUCOPHAGE XR (metformin hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, are the subject of NDA 021202, held by EMD
Serono Inc. and initially approved on October 13, 2000. GLUCOPHAGE XR
is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Harman Finochem Ltd. submitted a citizen petition dated August 17,
2019 (Docket No. FDA-2019-P-3877), under 21 CFR 10.30, requesting that
FDA confirm that GLUCOPHAGE (metformin hydrochloride) oral tablets were
not withdrawn from sale for reasons of safety or effectiveness.
Although the citizen petition did not address the GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, those products have also been discontinued. On our own initiative,
we have also determined whether those products were withdrawn for
safety or effectiveness reasons.
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 GLUCOPHAGE (metformin hydrochloride) oral
tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that GLUCOPHAGE
(metformin hydrochloride) oral tablets were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, from sale. We have also independently evaluated relevant literature
and data for possible postmarketing 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 GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, 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 these
drug products. Additional ANDAs for these drug products 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: December 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28270 Filed 12-30-19; 8:45 am]
BILLING CODE 4164-01-P