Fresh from inking a pact for Juvista, Shire announced that the FDA had issued an approvable letter for its ADHD drug Intuniv. The agency has requested additional information on the therapy but Shire noted that the request was not unexpected and the company is on track to launch the drug next year. Intuniv is a non-stimulant therapy, which should give it an advantage over the stimulants on the market for ADHD.
- see the release
- read the AP report on the FDA action