Notice2025-06050
Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
April 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 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
<html>
<head>
<title>Federal Register, Volume 90 Issue 67 (Wednesday, April 9, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Page 15243]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06050]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0515]
Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet,
100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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, the Agency, or we) has
determined that FLUMADINE (rimantadine hydrochloride) tablet, 100
milligrams (mg), was not withdrawn from sale for reasons of safety or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 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: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#aaebddc584ebd8c9c2cbc7dac5c4cd87edd8cbd3eacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="a2e3d5cd8ce3d0c1cac3cfd2cdccc58fe5d0c3dbe2c4c6c38ccacad18cc5cdd4">[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
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, is the
subject of NDA 019649, held by Sun Pharmaceutical Industries Inc. (Sun
Pharma), and initially approved on September 17, 1993. FLUMADINE is
indicated for the prophylaxis and treatment of illness caused by
various strains of influenza A virus in adults (17 years and older) and
for prophylaxis against influenza A virus in children (1 year to 16
years of age).
In a letter dated November 27, 2023, Sun Pharma notified FDA that
FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec. 314.161 that FLUMADINE
(rimantadine hydrochloride) tablet, 100 mg, was not withdrawn from sale
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of FLUMADINE (rimantadine
hydrochloride) tablet, 100 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 this drug product was not withdrawn for sale for reasons of safety
or effectiveness.\1\
---------------------------------------------------------------------------
\1\ Due to high levels of adamantane resistance among
circulating influenza A viruses, the Centers for Disease Control and
Prevention currently states on its website that adamantanes
(amantadine and rimantadine) are not recommended for antiviral
treatment or chemoprophylaxis of currently circulating influenza A
virus strains. Consistent with this, the current label for FLUMADINE
(rimantadine hydrochloride), 100 mg tablet, was revised to caution
prescribers to consider available information on influenza drug
susceptibility patterns and treatment effects when deciding whether
to use FLUMADINE.
---------------------------------------------------------------------------
Accordingly, the Agency will continue to list FLUMADINE
(rimantadine hydrochloride) tablet, 100 mg, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to FLUMADINE. Additional ANDAs that refer to
FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, may be approved
by the Agency if they comply with relevant legal and regulatory
requirements. 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 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06050 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 9, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.