Mylan Pharmaceuticals Inc., a subsidiary of Mylan Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quinine Sulfate capsules USP, 324 mg. This product is the generic version of Mutual Pharmaceutical Company, Inc.'s Qualaquin capsules, and is an antimalarial drug indicated only for treatment of uncomplicated plasmodium falciparum malaria.

Quinine Sulfate capsules USP, 324 mg, had US sales of approximately $31.9 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan has begun shipping this product.

Currently, Mylan has 178 ANDAs pending FDA approval representing $79.2 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.

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