Posted by Michael Wonder on 22 May 2018
Utility receives qualified infectious disease product designation from the U.S. FDA
21 May 2018 – Utility Therapeutics today announced that the U.S. FDA has designated both mecillinam (injectable) and pivmecillinam (oral prodrug) as qualified infectious disease products for the indication of complicated urinary tract infections.
On 16th May 2018 Utility announced an exclusive license agreement with Leo Pharma on access to Leo Pharma’s complete dataset for mecillinam and pivmecillinam, with the intent of gaining approval of the products in the U.S.
