Mylan Preparing Response To Generic Advair CRL, And It Needs A Win
After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.
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Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.
With US generic drug price erosion running at double digits, 2017 is expected to be a challenging year for the generic drug sector. Manufacturers are looking increasingly to complex generics, injectables and biosimilars as an offset, but it's unclear if wins in those areas will be enough to bridge the growth divide.
FDA issued a complete response letter for Hikma's ANDA to market a generic version of GSK's Advair, the second application to be rejected by FDA.