FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FHTA LLC; WITHDRAWAL OF APPROVAL OF NEW DRUG APPLICATION FOR MYSOLINE (PRIMIDONE) SUSPENSION, 250 MILLIGRAMS/5 MILLILITERS

WASHINGTON, Sept. 29 -- Food and Drug Administration has issued a notice called: FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters.

The notice was published in the Federal Register on Sept. 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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.

For more information, contact Aaron Young, Center for Drug Evalu...