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Mylan Unveils Generic Fenoglide Tablets

R. Chandrasekaran

Mylan N.V. (NASDAQ: MYL) unveiled Fenofibrate Tablets USP, 40 mg and 120 mg, which is a generic version of Santarus's Fenoglide, in the United States.

According to the company, it got final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product. Incidentally, the product was indicated as adjunctive therapy to diet to cut elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides, and apolipoprotein B to lift high-density lipoprotein in adult patients with mixed dyslipidemia or primary hypercholesterolemia.

Mylan said Fenofibrate Tablets USP, 40 mg and 120 mg, had sales of approximately $28.6 million for the 12 months ending April 30 in the United States based on IMS Health.

The company indicated it has 246 ANDAs currently that is pending for FDA approval and accounted for $107.4 billion in annual brand sales, according to IMS Health. The company added that Forty-three of these pending ANDAs have the potential to be first-to-file opportunities, accounting for $37.2 billion in annual brand sales, for the 12 months ending 2015, according to IMS Health.

Shares of the company traded down by 0.26 percent on Wednesday.

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