Mylan gets FDA OK for generic Zocor

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PITTSBURGH — Mylan Inc.’s Matrix Laboratories Ltd. subsidiary has received final approval from the Food and Drug Administration for simvastatin tablets, which treat high cholesterol.

Mylan said Friday that the FDA gave the OK for Matrix’s abbreviated new drug application (ANDA) for simvastatin tablets USP in 5 mg, 10 mg, 20 mg, 40 mg and 80 mg dosages.

The tablets, to be distributed by Mylan Pharmaceuticals Inc., are a generic version of Merck & Co.’s Zocor tablets

According to Mylan, simvastatin tablets had U.S. sales of about $361 million for the 12 months ended March 31, based on IMS Health data.

On Thursday, Mylan announced that its Mylan Pharmaceuticals subsidiary received final FDA approval for hydroxyzine hydrochloride tablets in 10 mg, 25 mg and 50 mg doses.

The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Pliva’s hydroxyzine hydrochloride tablets, a treatment for nervousness and tension, Mylan reported.

Hydroxyzine hydrochloride tablets generated U.S. sales of roughly $55 million for the year ended March 31, according to IMS Health figures cited by Mylan.


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