August Full Approvals
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
P: Priority Review (drug represents therapeutic gain over existing therapies) S: Standard review V: Orphan Drug 1: New molecular entity 2: New Salt 3: New formulation 4: New combination 5: Already marketed in U.S. by another firm 6: Already marketed by same firm, usually a new indication 7: First NDA for already marketed drug