Generics
Mylan NV unveils Mesalamine Delayed-Release Tablets USP in 1.2 g for management of ulcerative colitis in US patients
18 December 2018 -

Pharmaceutical company Mylan NV (NASDAQ:MYL) reported on Monday the availability of Mesalamine Delayed-Release Tablets USP in 1.2 g in the US gastroenterology market.

The company added that the Mesalamine Delayed-Release Tablets USP in 1.2 g is the generic version of Shire's Lialda Delayed-Release Tablets.

According to the company, the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Mesalamine Delayed-Release Tablets USP in 1.2 g for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

For the 12 months ending 31 October 2018, the US sales for Mesalamine Delayed-Release Tablets USP in 1.2 g were approximately USD842m, according to IQVIA.

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