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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth