FDA Releases New Guidance for ADHD Generic

October 24, 2017

The FDA issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

The guidance outlines the agency’s preferred design of bioequivalence studies to support ANDAs.

Methylphenidate HCl was initially approved as a new drug in 1982, and has been marketed as Ritalin, Concerta and several other brand names. It is used to treat attention deficit hyperactivity disorder.

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