FDA approves first generic versions of Lilly’s ADHD drug
pharmafile | May 31, 2017 | News story | Research and Development, Sales and Marketing | ADHD, Apotex, Aurobindo, FDA, Glenmark, Teva
The FDA has given its approval for the commercialisation of the first-ever generic versions of Eli Lilly’s Strattera (atomoxetine) for the treatment of children and adults with attention-deficit/hyperactivity disorder (ADHD) in the US.
Apotex, Teva Pharmaceuticals USA, Aurobindo and Glenmark have been given the go-ahead to manufacture the generic drug in a range of strengths. The products will be available immediately.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” commented Kathleen Uhl, Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
A selective norepinephrine reuptake inhibitor, atomoxetine must be dispensed alongside a patient medication guide and with a black boxed warning against the increased risk of suicidal ideation in paediatric users of the medication. It is also known to increase the risk of severe liver damage and serious cardiovascular events.
“Patients taking this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behaviour, especially during the initial few months of a course of drug therapy, or at times of dose changes,” explained the FDA’s release accompanying the news. “Other important warnings include the risk of severe liver damage and potential for serious cardiovascular events.”
Matt Fellows
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