Hikma Pharmaceuticals said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline’s blockbuster lung drug Advair at this time, due to ‘major’ issues with its application.
LONDON Hikma Pharmaceuticals said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline’s blockbuster lung drug Advair at this time, due to ‘major’ issues with its application.
The company said there was a low likelihood of approval this year.
Hikma and its partner Vectura are in a race with Mylan to bring the first substitutable generic version of Advair to the U.S. market. The U.S. Food and Drug Administration has already delayed approval of Mylan’s generic.
(Reporting by Ben Hirschler)
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