Mylan gains FDA approval for generic Pristiq in extended-release form

Sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31.
Sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31. | File photo
Mylan N.V. recently launched its Desvenlafaxine extended-release tablets, a generic version of Pfizer’s Pristiq tablets, to treat major depressive disorder in the U.S. market in 50 and 100 mg doses.
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.
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Mylan Inc. 1000 Mylan Blvd. Canonsburg, PA 15317