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.
© Copyright 2007 Insight Journal Online Magazine.
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