FDA approves Padagis’ generic budesonide rectal foam for ulcerative colitis

Padagis received FDA approval of its abbreviated new drug application for budesonide 2mg rectal foam for the induction of remission in patients with mild to moderate ulcerative colitis, according to a manufacturer release.
The FDA has also designated Padagis’ product as a competitive generic therapy, which effectively prevents approval of other ANDAs for this indication for a period of 180 days.
“This launch exemplifies the unique development, clinical and manufacturing technologies native to Padagis,” Pam Hoffman, president of Padagis, said in a press release. “Further,

Padagis received FDA approval of its abbreviated new drug application for budesonide 2mg rectal foam for the induction of remission in patients with mild to moderate ulcerative colitis, according to a manufacturer release.
The FDA has also designated Padagis’ product as a competitive generic therapy, which effectively prevents approval of other ANDAs for this indication for a period of 180 days.
“This launch exemplifies the unique development, clinical and manufacturing technologies native to Padagis,” Pam Hoffman, president of Padagis, said in a press release. “Further,