Rhone-Poulenc Rorer Rilutek (riluzole) for ALS approved Dec. 12, five-and-a-half months after NDA submission.
Executive Summary
RPR's RILUTEK FOR ALS WILL BE AVAILABLE WITHIN SIX WEEKS following FDA approval of the first treatment for patients with amyotrophic lateral sclerosis (Lou Gehrig's disease) on Dec. 12. Rhone-Poulenc Rorer said its "number one goal is to make the drug available to ALS patients as quickly as possible." Rilutek will be available within six weeks as a 50 mg tablet to be administered twice daily. The company will officially launch the product Jan. 10 when it will discuss availability and patient support services.