Declan schreef op 9 oktober 2014 17:10:
The FDA has granted final approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis, according to a company press release.
The final FDA approval of Budesonide (Uceris, Salix Pharmaceuticals) 2 mg rectally-administered corticosteroid has been granted after expiration of the 45-day waiting period following the tentative approval granted on September 15, the release said.
This previous tentative approval followed two phase 3 studies that found significantly higher achievement of remission, and improvements in disease activity and rectal bleeding.
The product is expected to launch in early 2015.
Pharming staat binnenkort ook gewoon als winner in een PB van Salix.
Ruud..