5 November 2019 - Crescita Therapeutics today announced that the U.S. FDA approved the enhanced formulation of Pliaglis® (the "Enhanced Formulation") following its statutory six-month review process and in line with the target action date under the Prescription Drug User Fee Act ("PDUFA"). 

While the U.S. patent covering the original formulation of Pliaglis® expired on September 28. 2019, the U.S. patent covering the Enhanced Formulation with extended protection to 2031, is in the process of being added to the Orange Book.

Read Crescita Therapeutics press release