Hikma, Vectura in dispute with FDA over generic Advair
LONDON: Hikma and its partner Vectura are in dispute with the Food and Drug Administration over their plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the U.S. market, delaying any eventual approval.
Hikma said on Thursday it expected the dispute process to be completed in the first quarter of 2018, at which point it would “update the market and provide further details on timelines”.
(Reporting by Ben Hirschler; editing by Tom Pfeiffer)
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