US FDA approves Mylan's generic Sarafem
US generic drugmaker Mylan has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for fluoxetine capsules 10mg and 20mg.
Indicated for the treatment of premenstrual dysphoric disorder, the agent is the generic version of US drug major Eli Lilly's Sarafem Pulvules capsules, which had annual US sales of approximately $19.2 million for the 12 months ending September 30, for the noted strengths, according to IMS Health. Shipment of the product will begin immediately.
Currently, Mylan says it has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
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