Mylan launches generic Dexedrine capsules
CANONSBURG — Mylan N.V. on Monday announced the U.S. launch of dextroamphetamine sulfate extended-release capsules, in 5-, 10- and 15-mg capsules, a generic version of Amedra Pharmaceuticals LLC’s Dexedrine.
Southpointe-based Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 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 to 16 years with this syndrome.
The medicine had U.S. sales of $101.3 million for the 12 months ending May 31, according to IMS Health.