Unimed’s Marinol
Executive Summary
New indication for anorexia associated with AIDS receives "NDA Day" review by FDA on Dec. 2. Representatives of Unimed and Marinol marketing partner Roxane traveled to Rockville, Md. to answer questions posed by FDA reviewers. The meeting was "very positive," Unimed said, indicating that approval for the indication is possible in the "near future." Unimed filed for the new indication on Aug. 18; Marinol (dronabinol) is already marketed as an antiemetic for chemotherapy patients.