FDA approves 2 more dosage strengths of Impax’s Focalin XR generic

SILVER SPRING, Md. — The Food and Drug Administration has approved two additional dosage strengths for Impax Laboratories’ generic of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules.

The approval was given for 25- and 35-mg dosage strengths of the drug, and Impax said it has immediately begun commercialization activities. The approval adds to the 5-, 10-, 15-, 20- and 30-mg capsules the company has previously launched of the generic.

The drug is indicated to treat attention deficit hyperactivity disorder in patients ages 6 years and older. The 25-and 35-mg dosage strength capsules had U.S. sales of approximately $93 million for the 12 months ended May 2017, according to QuintilesIMS data.