Pozen to submit response for migraine drug within 10 days
Oct 5 (Reuters) - U.S. drugmaker Pozen Inc (POZN.O) said within the next ten days it plans to respond to U.S. regulators, clarifying non-clinical information to further address concerns regarding the genotoxic potential of Trexima.
It will also submit a routine clinical safety update.
The move is in response to the approvable letter for migraine drug Trexima received on Aug. 1 from the U.S. Food and Drug Administration, the company said in a statement. (Reporting by Sreerupa Mitra in Bangalore)