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Mylan gets US FDA approval for 1st generic of Allergan's bowel disease drug

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Mylan gets US FDA approval for 1st generic of Allergan's bowel disease drug

Mylan NV has received the U.S. Food and Drug Administration's approval to launch the first generic of Allergan PLC's inflammatory bowel disease therapy Canasa Rectal Suppository.

The drug, also called mesalamine rectal suppository, is approved in the U.S. to treat mildly to moderately active ulcerative proctitis, which causes inflammation of the lining of the rectum.

Mylan said it will be eligible for 180 days of generic-drug exclusivity since the Canonsburg, Pa.-based company was the first to submit a substantially complete application to the FDA.

The drug had U.S. sales of about $263 million for the 12 months ending October 31, Mylan said, citing figures from research firm IQVIA.