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US FDA approves Mylan's generic ADHD drug

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US FDA approves Mylan's generic ADHD drug

Mylan NV received final approval from the U.S. FDA for its abbreviated new drug application for Methylphenidate Hydrochloride extended-release tablets, a generic version of Janssen Pharmaceuticals Inc.'s Concerta tablets.

The product is intended for the treatment of attention deficit hyperactivity disorder.

Mylan also launched the generic product in the U.S. Methylphenidate Hydrochloride extended-release tablets had sales of about $1.59 billion in the U.S. for the 12 months ending Oct. 31, according to data from IMS Health.