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Mylan launches pair of new generics in U.S.

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PITTSBURGH — Mylan N.V. this week introduced two new generic drugs in the U.S. market.

On Monday, the company announced final Food and Drug Administration approval for dextroamphetamine sulfate extended-release capsules — in dosages of 5 mg, 10 mg and 15 mg — and finasteride tablets 1 mg.

Mylan’s dextroamphetamine sulfate ER capsules are a generic version of Amedra Pharmaceuticals’s Dexedrine, a treatment for narcolepsy and attention deficit disorder with hyperactivity, and its finasteride product is a generic version of Merck’s Propecia, used for the treatment of pattern hair loss in men.

U.S. sales for the 12 months ended May 31 totaled $101.3 million for dextroamphetamine sulfate ER capsules (5 mg, 10 mg and 15 mg) and $35.3 million for finasteride tablets (1 mg), according to IMS Health data reported by Mylan.


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