First Generic for Canasa Approved

December 17, 2018 – The U.S. FDA has approved Mylan’s generic for Allergan’s Canasa® (mesalamine) 1,000mg rectal suppositories. This is the first generic for the product to receive FDA approval, and Mylan will have 180 days of exclusivity.

Canasa and its generic are indicated to treat mildly to moderately active ulcerative proctitis, an inflammatory bowel disease and form of ulcerative colitis (UC). Ulcerative proctitis typically affects only the rectum, but can develop into other forms of UC over time. Patients with UC develop inflammation and ulcers in the colon, which affect the functioning of the digestive tract.

Recommended dosing with 1,000mg mesalamine rectal suppositories is one suppository inserted once daily at bedtime for three to six weeks. Safety and efficacy beyond six weeks have not been established. Mylan has not yet announced launch or pricing plans for its generic.