Mylan NV 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.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, 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 U.S. sales of approximately $101.3 million for the 12 months ending May 31, 2016, according to IMS Health.
Currently, Mylan 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 December 31, 2015, according to IMS Health.