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Mylan releases Micronor, Viagra generics

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PITTSBURGH — Mylan Inc. has launched generic versions of Micronor in the United States and Viagra in Europe.

The pharmaceutical manufacturer said Wednesday that it has released in the U.S. norethindrone tablets 0.35 mg, a generic of Janssen Pharmaceuticals’ Micronor Tablets 0.35 mg (28-day cycle), indicated for the prevention of pregnancy.

Mylan said its partner, Famy Care Ltd., received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for the product.

Norethindrone tablets 0.35 mg had U.S. sales of about $57.2 million for the 12 months ended March 31, according to IMS Health data reported by Mylan.

Also on Wednesday, Mylan announced that it has rolloed out sildenafil citrate tablets in dosages of 25 mg, 50 mg and 100 mg in France, the United Kingdom, Ireland, Italy, Belgium, Slovakia, Germany, Denmark, Czech Republic, Spain and the Netherlands.

The company said it has received marketing authorization from each nation’s health authority to begin selling the product immediately. Sildenafil citrate is the generic version of Pfizer’s Viagra, a medication for erectile dysfunction.

Citing IMS Health figures, Mylan said Viagra had total sales of 241.1 million euros ($310.4 million U.S.) in France, the United Kingdom, Ireland, Italy, Belgium, Slovakia, Germany, Denmark, Czech Republic, Spain and the Netherlands for the 12 months ended March 31.

Earlier this week, Actavis Inc. and Teva Pharmaceutical Industries Ltd. also launched generic versions of Viagra in Europe with the expiration of Pfizer’s patent in the region. In the United States, Pfizer’s U.S. patent for Viagra is due to expire in 2020.


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