FDA Affirms FLUMADINE Was Not Withdrawn Over Safety or Efficacy Concerns
April 09, 2025
April 09, 2025
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has concluded that FLUMADINE (rimantadine hydrochloride) 100 mg tablets, manufactured by Sun Pharmaceutical Industries Inc., were not withdrawn from the market due to safety or effectiveness issues. This decision clears the way for continued approval of generic versions of the antiviral drug, which had been discontinued for marketing but remains listed in the FDA's Orange Book under . . .