Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic
FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.
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Teva's decision to launch an authorized generic version of AirDuo, a drug made up of the same active ingredients in GSK's Advair, at a steep discount to typical brand drugs for asthma will help encourage use, even though it is not interchangeable.
Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.
The company is seeking FDA accelerated approval of the closely watched gene therapy based on a surrogate marker and has proposed its fully enrolled Phase III trial to serve as a confirmatory study.