FDA approves Padagis’ generic budesonide rectal foam for ulcerative colitis
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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, the [competitive generic therapy] exclusivity awarded to the Padagis ANDA highlights our ability to successfully navigate the regulatory environment and commercialize this important product for our customers and patients.”
The FDA determined that, among adult patients with mild to moderate UC, Padagis’ 2 mg product is therapeutically equivalent to Salix Pharmaceuticals’ Uceris rectal foam, which was used as a reference product. However, as with Uceris, the safety and efficacy of Padagis’ generic among children is not yet known.
According to the FDA, the most common adverse events associated with budesonide 2mg rectal foam include decreased blood cortisol, adrenal insufficiency and nausea.
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