Mylan has launched a generic version of Canasa Rectal Suppository 1000mg (mesalamine; Allergan), indicated for the treatment of mild-to-moderate active ulcerative proctitis.
According to the FDA approval letter, the Company was the first to submit a complete Abbreviated New Drug Application for Mesalamine Rectal Suppository, 1000mg and is eligible for 180 days of generic drug exclusivity.
Mesalamine is also known as mesalazine or 5-aminosalicylic acid (5-ASA), and while its mechanism of action is not fully understood, it appears to be topical rather than systemic. Although the pathology of inflammatory bowel disease is uncertain, both prostaglandins and leukotrienes have been implicated as mediators of mucosal injury and inflammation.
Mesalamine suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates.
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