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FDA Denies Mylan Petition on Advair Generics

Posted 10 May 2018 | By Zachary Brennan 

FDA Denies Mylan Petition on Advair Generics

The US Food and Drug Administration (FDA) announced Thursday that it has denied Mylan’s petition that sought to block certain generic applications for Advair (fluticasone propionate and salmeterol).

After receiving a complete response letter (CRL) for its generic Advair in March 2017, Mylan had argued in a December 2017 petition that FDA refrain from approving generic versions of Advair, which are inhalers for asthma and COPD made by GlaxoSmithKline, if they rely on multiple-batch pharmacokinetic bioequivalence study designs unless FDA concludes that such study designs are valid. Some have suggested the petition targeted Sandoz's Advair generic.

In its response rejecting the petition, FDA said it has not made any final determinations on approving generic versions of the inhaler. FDA also rejected previous citizen petitions from GSK and Sandoz.

But bringing generic versions of Advair to market has proven to be a tricky situation, and not just for Mylan.

Novartis’ Sandoz also received a CRL for its generic and so did Hikma and Vectura for their version this March.

Sandoz has said it plans to launch generics either later this year or in 2019, while Hikma said FDA called for another clinical trial to get its generic approved and it anticipates another submission in 2019.

GSK predicted that after a mid-2018 introduction of a substitutable generic competitor to Advair in the US, full year 2018 US sales would be around £750 million ($1 billion). GSK said 2017 sales of the drug, first approved in 2000, were £3.13 billion ($4.23 billion).

According to GoodRx, Advair prices have increased by about 35% between January 2013 and 2017.

Petition Denial Letter From CDER to Mylan

Categories: Regulatory News

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