IMPAX gains another ANDA, for riluzole

IMPAX Laboratories says that the US Food and Drug Administration hasgranted tentative approval for its Abbreviated New Drug Application on a generic version of Aventis' Rilutek (riluzole 50mg) tablets, for the treatment of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. According to IMS Health, US sales of Rilutek were $35 million for the 12 months ended March 31.

Final FDA approval is contingent upon the expiration of orphan drug exclusivity on December 12 and resolution of the patent litigation that IMPAX has initiated against Aventis regarding a patent recently listed by the drug major in the FDA Orange Book, as well as the FDA's evaluation of any new information subsequent to this tentative approval.