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Methylphenidate generics: ‘Approved’ vs. ‘authorized’
Publication year - 2015
Publication title -
the brown university child and adolescent psychopharmacology update
Language(s) - English
Resource type - Journals
eISSN - 1556-7567
pISSN - 1527-8395
DOI - 10.1002/cpu.30018
Subject(s) - mallinckrodt , bioequivalence , citation , methylphenidate , medicine , alternative medicine , psychology , family medicine , business , pharmacology , law , psychiatry , political science , attention deficit hyperactivity disorder , pathology , bioavailability
In the “From the FDA” section in the January issue, in the article about the FDA's concerns about bioequivalence of methylphenidate generics, we wrote that there are two “approved” generics for Concerta, manufactured by Mallinckrodt and Kudco. Both of these are under question in terms of bioequivalence, with the two companies being told by the FDA that they have six months to use revised standards or to withdraw their drugs from the market. Farther down in the story we refer to the “authorized” generic, which is made by Janssen, the same company that makes Concerta, and marketed by Actavis. The Actavis product meets bioequivalence standards and is “identical to Concerta.” An astute reader noted that most clinicians may not understand the difference between “approved” and “authorized.” Indeed, FDA press officer Sandy Walsh clarified this.