Orion Comtan Approval Hastened by FDA Tasmar Concerns
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Approval of Orion’s Comtan (entacapone) appears to have been accelerated because of the drug’s favorable liver toxicity profile in comparison to Roche’s competing catechol-O-methyl transferase (COMT) inhibitor Tasmar (tolcapone), FDA review documents indicate.