Padagis, a provider of extended topical and other specialty pharmaceuticals primarily to the United States and Israel, announced on Friday that it has introduced its Budesonide 2mg Rectal Foam (generic to Uceris) with 180 days of Competitive Generic Therapy exclusivity.
Uceris, a prescription corticosteroid medicine, is intended to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control. It is not known if the product is safe and effective in children.
Padagis president, Pam Hoffman, said: "This launch exemplifies the unique development, clinical and manufacturing technologies native to Padagis. Further, the CGT exclusivity awarded to the Padagis ANDA highlights our ability to successfully navigate the regulatory environment and commercialise this important product for our customers and patients."
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