- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- Diplomat becomes distributor of recently approved cancer drug
- FDA advisory panel to consider OTC status of NSAIDs
- FDA advisory committees turn down Primatene HFA application for OTC status
PHILADELPHIA — The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.
The FDA approved Intuniv (guanfacine) as an add-on therapy for children and adolescents already taking stimulants to treat ADHD, also known as an adjunctive therapy.
The approval was based on a nine-week placebo-controlled study of the drug in which children and adolescents received it in combination with a stimulant.