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Merck’s Zolinza Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck’s NDA for Zolinza for the treatment of advanced cutaneous T-cell-lymphoma (CTCL) has been granted priority review by the FDA. A priority review designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review and act on NDAs designated as priority review within six months of receipt. Merck expects FDA action on the NDA by early October of this year. If approved, Zolinza would potentially be...

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