SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced its approval of the first generic versions of Strattera (atomoxetine), a treatment for attention-deficit/hyperactivity disorder in children and adults.
Apotex, Aurobindo, Teva and Glenmark all earned approval from the regulatory agency to market the drug in multiple strengths.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” Dr. Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research said. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
The drug is dispensed with a boxed warning about increased risk of suicidal ideation in children and adolescents.
May 31, 2017