FDA approves Impax’s generic extended-release Concerta

SILVER SPRING, Md. — The Food and Drug Administration has approved Impax Laboratories’ generic of Concerta (methylphenidate hydrochloride) extended-release tablets. The drug is indicated too treat attention deficit hyperactivity disorder in patients older than 6 years of age.

 

“Approval of our AB-rated generic version of Concerta further demonstrates the capabilities of Impax's R&D organization,” Impax president and CEO Paul Bisaro said. “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.”

 

Impax’s generic will be available in 18-, 27-, 36- and 54-mg dosage strengths. The drug had U.S. sales of approximately $1.8 billion for the 12 months ended May 2017, according to QuintilesIMS data.