FDA approves Impax’s generic Intuniv

HAYWARD Calif. — Impax Laboratories announced Thursday that the Food and Drug Administration had approved its generic version of Shire’s Intuniv (guanfacine) extended-release tablets.

The drug is indicated to treat attention deficit/hyperactivity disorder in children and adolescents ages 6 to 17. The drug will be available from Impax in 1-, 2-, 3- and 4-mg dosage strengths.

For the 12 months ended August 2015, brand and generic sales of guanfacine extended-release tablets were about $689 million.