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BioPharmaceutical

Pfizer Indiplon “Refuse To File” For eNDA May Stem From Shift In FDA Oversight

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Executive Summary

FDA's shift of responsibilities for Pfizer/Neurocrine's insomnia drug indiplon between review divisions may have led to the agency's delay in accepting the NDA
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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