FDA approves Impax's AB rated generic Concerta Extended-Release Tablets CII

Impax Laboratories has received an AB therapeutic equivalent rating and final FDA approval on its Abbreviated New Drug Application (ANDA) for a generic version of Concerta (methylphenidate hydrochloride) Extended-Release tablets USP CII, 18, 27, 36 and 54 mg.

"Approval of our AB-rated generic version of Concerta further demonstrates the capabilities of Impax's R&D organization," said Paul Bisaro, President and Chief Executive Officer of Impax. "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."

Methylphenidate hydrochloride extended-release tablets had US sales of approximately $1.8 billion, according to IMS Health for the 12 months ending May 2017.

Methylphenidate hydrochloride extended-release tablets, are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.