FDA News

FDA approves NDA for generic extended-release Concerta

Paul Bisaro
Paul Bisaro

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.”

Paul Bisaro
Paul Bisaro

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.”