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Mylan's version, called Fluoxetine Capsules USP, was approved in 10 mg and 20 mg form. The Lilly original had annual U.S. sales of around $19.2 million for the twelve months ending September 30, for the noted strengths, according to IMS Health.
Mylan said that shipment of its product will begin immediately.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Pittsburgh-based Mylan is a generic and specialty pharmaceutical firm that provides products to customers in more than 140 countries and territories.
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