The decision to take on America’s Food and Drug Administration was always a bold one from Hikma Pharmaceuticals. Yesterday the FTSE 250 generic drugs company updated investors that, perhaps unsurprisingly, it had failed.
At stake is Hikma’s attempt to secure regulatory approval in the United States for its generic version of Advair, the blockbuster asthma inhaler sold by Glaxosmithkline. America is Hikma’s biggest market and its generic product was acquired through its purchase of Roxane in 2016, the latest leg in Hikma’s expansion. Since it was founded in 1978 the company, based in Jordan, has built up a presence in more than 50 countries.
The FDA withheld approval for Hikma’s version last May, ruling in a so-called complete response letter that the application required significant