Mylan Sees A Difference In Having Generic Drug User Fees
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.
Management at Mylan NVsaid FDA’s Office of Generic Drugs has offered a high-level of engagement when it comes to reviewing the company’s ANDA for a generic version of GlaxoSmithKline PLC’s blockbuster asthma drug Advair Diskus (fluticasone/salmeterol).
The progress is encouraging to Mylan, which is hopeful for a first round review, management said during Mylan’s second quarter...
