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New River Pharmaceuticals, Shire receive approvable letter for Vyvanse
Published in Medical Letter on the CDC and FDA, January 28th, 2007
The FDA issued an approvable letter for Vyvanse and New River Pharmaceuticals submitted a complete response to the FDA.
No additional studies have been requested by the FDA as a condition for approval of Vyvanse. The companies will work together to provide full and timely responses to the agency's request. The data requested are routine and their...
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