FDA approves Neos Therapeutics’ Adzenys XR-ODT

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a new treatment for attention deficit/hyperactivity disorder from Neos Therapeutics. The company’s Adzenys-XR ODT (amphetamine) is an extended release orally disintegrating tablet that patients take once daily. 

 

“The novel features of an extended-release orally disintegrating tablet, which is dosed once daily and disintegrates in the mouth, make Adzenys XR-ODT attractive for use in both children (six years and older) and adults,” said Dr. Alice Mao, medical director at Memorial Park Psychiatry in Houston, Texas. 

 

The drug is a bioequivalent to Adderall XR and will be available in 3.1-, 6.3-, 9.4-, 12.5-, 15.7- and 18.8-mg dosage strengths.