Mylan launches Mesalamine Delayed-Release Tablets USP in US
18 December 2018 -

Mylan NV (NASDAQ: MYL), a global pharmaceutical company, is launching its Mesalamine Delayed-Release Tablets USP, 1.2g, a generic version of Shire's Lialda Delayed-Release Tablets, in the US.

It was reported yesterday that the company received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product that is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Presently, the company has 168 ANDA's pending US FDA approval, representing around USD85.5bn in annual brand sales, according to IQVIA. Forty-four of these pending ANDA's are potential first-to-file opportunities, representing USD50.4bn in annual brand sales, for the 12 months ending 30 June 2018, according to IQVIA.