Mylan’s Advair Copycat Drug Rejected By FDA


The FDA has rejected Mylan’s first attempt to produce a generic version of GlaxoSmithKline’s asthma treatment Advair. If the generic had been approved, GSK would have seen its top selling drug take a major sales hit. Although Mylan’s Advair generic was rejected, the FDA is still set to decide on approval of another Advair copycat from Hikma Pharmaceuticals and Vectura. That decision is expected to come by May 10th. Mylan has announced that it will review the FDA response and provide updates “as soon as practicable.”

Read the source article at BioPharmaDIVE

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