New River Pharmaceuticals Inc. and its collaborative partner Shire announced recently that the FDA has issued a second approvable letter for Vyvanse for treating attention deficit hyperactivity disorder (ADHD). On October 6, 2006 the Food and Drug Administration issued an approvable letter for Vyvanse and New River Pharmaceuticals submitted a complete response to the FDA on October 24, 2006.
The FDA has not requested any additional studies as a condition for approval of the drug. The companies will work together to provide full and timely responses to the FDA’s request. The data requested are routine, and their provision to the FDA is not expected to delay a launch of Vyvanse in the second quarter of 2007. The US Drug Enforcement Agency’s parallel review of Vyvance’s scheduling assignment is expected within three months.
The FDA is pushing for the drug to be classified as a Schedule II controlled substance. The proposal has been submitted to the DEA. Once Vyvanse is approved by the FDA and receives final scheduling designation by the DEA, Vyvanse will be available in three dosage strengths: 30mg, 50mg and 70mg, all indicated for once-daily dosing.