trending Market Intelligence /marketintelligence/en/news-insights/trending/f3kkq2hmybwmohzoofhspg2 content esgSubNav
In This List

US FDA flags deficiencies in Mylan's generic of GSK's Advair Diskus

Blog

Baird Research is Now Exclusively Available in S&P Global’s Aftermarket Research Collection

Blog

Japan M&A By the Numbers: Q4 2023

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity


US FDA flags deficiencies in Mylan's generic of GSK's Advair Diskus

The U.S. Food and Drug Administration has found minor deficiencies in Mylan NV's application for a generic version of GlaxoSmithKline PLC's blockbuster asthma treatment Advair Diskus.

Advair Diskus generated £3.13 billion in full-year 2017 global revenues, including £1.61 billion in the U.S.

Canonsburg, Pa.-based Mylan said it expects the regulator to issue a complete response letter identifying the issues on June 27.

The application for the product has received a priority designation, and Mylan believes it could get approval for the treatment before the standard 90-day time period after the date of its response to the FDA's letter.

In February, the FDA rejected Novartis AG's application for a generic version of Advair.