Mylan launches generic drugs to treat attention disorder, hair-loss in US

Mylan NV today announced the US launch of Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg, and 15 mg, a generic version of Amedra Pharmaceuticals LLC's Dexedrine extended-release capsules used to treat attention deficit/?hyperactivity disorder, and Merck's Propecia tablets used to treat male pattern hair loss.

Mylan said it has received final approval from the US Food and Drug Administration (FDA) for its   abbreviated new drug application (ANDA) for Dextroamphetamine Sulfate Extended-release Capsule, which is indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome.

Dextroamphetamine Sulfate Extended-release capsules, 5 mg, 10 mg, and 15 mg, had US sales of approximately $101.3 million for the 12 months ending 31 May 2016, according to IMS Health.

Mylan said it currently has 245 ANDAs pending FDA approval, representing $101.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $30.8 billion in annual brand sales, for the 12 months ending 31 December 2015, according to IMS Health.

Mylan said it has also received approval from federal regulators to offer a generic version of Merck's Propecia hair-loss treatment.

Mylan, which is based in Europe, launched the Finasteride Tablets USP, 1 mg, a generic version of Merck's Propecia, in the US. Propecia is used to treat male pattern baldness and had sales of $35.3 million for the year ended 31 May, according to IMS Health.