US FDA approves Symplmed and Servier's Prestalia

Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension, licensed from Servier, France’s largest independent pharma company.

Prestalia is the first fixed-dose combination of these two drugs which may be used as initial therapy. In Europe, Servier has submitted the registration file of this new fixed combination and the process is ongoing.

“This is a significant milestone for Symplmed and for our development partner Servier as it is the first fixed-dose combination including perindopril to receive FDA approval,” said Erik Emerson, president and chief executive of Symplmed Pharmaceuticals.