FDA knocks back Mylan’s Advair generic for second time

pharmafile | June 14, 2018 | News story | Sales and Marketing Advair, FDA, GSK, Mylan, pharma 

The FDA has rejected Mylan’s generic version of GlaxoSmithKline’s Advair for the second time following its knockback last year, citing “minor deficiencies” in its efficacy as reason for the decision.

The inhaled lung therapy was originally accepted for review in 2016, but has faced an uphill struggle since then to secure marketing authorisation. Mylan did not divulge the exact reasons for the rejection, but noted that it would be reviewing the complete response letter it expects to receive from the US regulator to assess its potential impact on 2018 financial projections. It remains unclear whether the issues outlined will be able to be resolved in order to secure approval this year. Shares for the company fell by 4.5% on the news.

Besides its earlier rejection, Mylan’s drug is not the only Advair generic to be knocked back by the FDA, with the organisation refusing to approve versions from Novartis and Hikma. The news bodes well for Advair’s owner GSK, whose own predictions may come to pass and leave it free of direct competition in the space for the rest of the year. The drug generated around $2.1 billion in the US for the company last year.

Matt Fellows

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