Notice2025-04020
Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 13, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 90 Issue 48 (Thursday, March 13, 2025)</title>
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[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11991-11992]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-P-0884 and FDA-2023-P-5687]
Determination That RIOMET (Metformin Hydrochloride) Oral
Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 11992]]
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that RIOMET (metformin hydrochloride) Oral Solution, 500
milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for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 this drug product, and it will allow
FDA to continue to approve ANDAs that refer to the product as long as
they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Tereza Hess, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 301-
796-1546, <a href="/cdn-cgi/l/email-protection#c5b1a0b7a0bfa4ebada0b6b685a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="9aeeffe8ffe0fbb4f2ffe9e9dafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, is the
subject of NDA 021591, held by Ranbaxy Signature LLC, and initially
approved on September 11, 2003. RIOMET is a biguanide 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.
In a letter dated November 14, 2022, Ranbaxy Signature LLC notified
FDA that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL
had been withdrawn from sale as of November 2019. RIOMET (metformin
hydrochloride) Oral Solution, 500 mg/5 mL is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Oryza Pharmaceuticals, Inc. submitted a citizen petition dated
March 9, 2023 (Docket No. FDA-2023-P-0884), under 21 CFR 10.30,
requesting that the Agency determine whether RIOMET (metformin
hydrochloride) Oral Solution, 500 mg/5 mL, was withdrawn from sale for
reasons of safety or effectiveness. Bionpharma, Inc. submitted a
citizen petition dated December 22, 2023 (Docket No. FDA-2023-P-5687)
under 21 CFR 10.30, also requesting that the Agency determine whether
RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, was
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 RIOMET (metformin hydrochloride) Oral
Solution, 500 mg/5 mL, has not been withdrawn from sale for reasons of
safety or effectiveness. The petitioners have identified no data or
other information suggesting that RIOMET (metformin hydrochloride) Oral
Solution, 500 mg/5 mL, was withdrawn from sale for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of RIOMET (metformin hydrochloride) Oral
Solution, 500 mg/5 mL, 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 this drug
product was not withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list RIOMET (metformin
hydrochloride) Oral Solution, 500 mg/5 mL, 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 this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04020 Filed 3-12-25; 8:45 am]
BILLING CODE 4164-01-P
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