Notice2026-19912
FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
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
September 29, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), held by FHTA LLC (FHTA). FHTA agreed to withdrawal of approval of this application and has waived its opportunity for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 187 (Tuesday, September 29, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Page 61408]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-10505]
FHTA LLC; Withdrawal of Approval of New Drug Application for
MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of new drug application (NDA) 010401 for MYSOLINE
(primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), held by
FHTA LLC (FHTA). FHTA agreed to withdrawal of approval of this
application and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of September 29, 2026.
FOR FURTHER INFORMATION CONTACT: Aaron Young, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-8083, <a href="/cdn-cgi/l/email-protection#1c7d7d6e737232657369727b5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="f49595869b9ada8d9b819a93b4929095da9c9c87da939b82">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA initially approved NDA 010401 for
MYSOLINE (primidone) suspension, 250 mg/5 mL, on July 5, 1956. In 2001,
MYSOLINE (primidone) suspension, 250 mg/5 mL, was discontinued after
antimicrobial effectiveness testing raised concerns about potential
microbial contamination, in particular with Pseudomonas aeruginosa. In
the Federal Register of January 2, 2026 (91 FR 148), FDA determined
that MYSOLINE (primidone) suspension, 250 mg/5 mL, was withdrawn from
sale for reasons of safety or effectiveness. FDA noted that, as a
scientific matter, before MYSOLINE (primidone) suspension, 250 mg/5 mL,
could be considered for reintroduction to the market, a reformulation
would be required including establishment of preservative content
acceptance criteria and correlation with passing antimicrobial
effectiveness testing results. FDA stated that the NDA holder for
MYSOLINE (primidone) suspension, 250 mg/5 mL, would have to demonstrate
the safety and effectiveness of the reformulated product. FDA further
stated that, at that time, no new formulation had been approved for
MYSOLINE (primidone) suspension, 250 mg/5 mL.
On June 12, 2026, FDA asked FHTA whether it intended to reformulate
MYSOLINE (primidone) suspension, 250 mg/5 mL, to establish preservative
content acceptance criteria and correlation with passing antimicrobial
effectiveness testing results, or whether FHTA would agree to waive the
opportunity for hearing and permit FDA to withdraw approval of NDA
010401 under 21 CFR 314.150(d) (Sec. 314.150(d)). FDA referred to its
determination that MYSOLINE (primidone) suspension, 250 mg/5 mL, was
withdrawn from sale for reasons of safety or effectiveness in
connection with concerns regarding potential microbial contamination,
in particular with Pseudomonas aeruginosa. On June 22, 2026, FHTA
responded that it was not seeking a hearing and agreed to withdrawal of
NDA 010401 pursuant to Sec. 314.150(d).
For the reasons discussed above, which FHTA does not dispute in its
response, and in accordance with FHTA's response, approval of NDA
010401 for MYSOLINE (primidone) suspension, 250 mg/5 mL, and all
amendments and supplements thereto, is withdrawn under Sec.
314.150(d). Distribution of MYSOLINE (primidone) suspension, 250 mg/5
mL, into interstate commerce without an approved application is illegal
and subject to regulatory action (see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19912 Filed 9-28-26; 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 September 29, 2026.
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.