In Brief: Roberts Pharmaceutical's ProAmatine
Executive Summary
Roberts Pharmaceutical's ProAmatine: Midodrine oral compound for orthostatic hypotension deemed "approvable" by FDA on June 7. The approvable status for the orphan drug is based on Subpart H accelerated approval for new drugs for serious or life-threatening disease. FDA says the approval of midodrine is based on its effect on the surrogate endpoint of raising standing blood pressure...