Subjects: PDT, FDA
PADAGIS ANNOUNCES FDA APPROVAL AND LAUNCH OF A-RATED GENERIC VERSION OF UCERIS® (BUDESONIDE 2MG RECTAL FOAM)
ALLEGAN, Mich., April 28, 2023 /PRNewswire/ -- Padagis today announced the launch of Budesonide 2mg Rectal Foam (generic to Uceris®) with 180-days of Competitive Generic Therapy exclusivity.
Uceris® is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission). It is not known if Uceris® rectal foam is safe and effective in children. Annual market sales for Uceris® were approximately $13 million in the 12 months ended March 2023 as measured by IQVIA.
Padagis President, Pam Hoffman, stated "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 commercialize this important product for our customers and patients."
About Padagis
Padagis is dedicated to improving the well-being of patients and consumers by providing high quality, affordable, specialized healthcare products. The company is a leading provider of extended topical and other specialty pharmaceuticals to its primary markets of the United States and Israel. Padagis employs over 1,300 people worldwide. Visit Padagis online at (http://www.padagis.com).
SOURCE Padagis
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