Mylan Launches Generic Pristiq Tablets

Mylan N.V., announced the U.S. launch of Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer’s Pristiq® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of major depressive disorder.

Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, had U.S. sales of approximately $853 million for the 12 months ending January 31, 2017, according to IMS Health.

Currently, Mylan has 241 ANDAs pending FDA approval representing approximately $100.9 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $39 billion in annual brand sales, for the 12 months ending December 31, 2016, according to IMS Health.