FDA Releases New Guidance for ADHD Generic
The FDA issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.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.