Mylan gains FDA approval for generic Pristiq in extended-release form
According to IMS Health, sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31. Mylan’s announcement of the tablets’ launch comes after it received final U.S. Food and Drug Administration on its Desvenlafaxine Extended-release Tablets Abbreviated New Drug Application (ANDA).
Mylan has another 241 ANDAs under review with the FDA, 45 of which are potential first-to-file opportunities. In total, the ANDAs represent approximately $100.9 in annual sales, while the 45 first-to-file opportunities account for $39 billion in sales, according to IMS Health figures.