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FDA approves NDA for generic extended-release Concerta
Impax Laboratories recently announced receipt of an AB therapeutic equivalent rating and final FDA approval for its abbreviated New Drug Application for a generic version of extended-release Concerta for ADHD.
The approved New Drug Application (NDA) is for 18-mg, 27-mg, 36-mg and 54-mg extended-release tablets of generic Concerta (methylphenidate hydrochloride).
Impax’s Concerta is approved for treatment of ADHD in children aged 6 years and older, adolescents, and adults aged up to 65 years.
“Approval of our AB-rated generic version of Concerta further demonstrates the capabilities of Impax’s R&D organization,” Paul Bisaro, president and CEO of Impax, said in a press release. “We are preparing for launch including working to secure API quota and currently expect to launch by the end of this year. As a result, we don’t anticipate sales of generic Concerta to meaningfully impact our earnings in 2017.”