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Mylan Sees A Difference In Having Generic Drug User Fees

Executive Summary

FDA is pushing forward with its review of Mylan’s ANDA for generic Advair, according to the company, which is gaining confidence that the application could receive a first round approval. The experience for that application, which has a generic drug user fee, is a clear contrast to the firm's experience with its pre-GDUFA Copaxone filing.


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