GSK wins Advair reprieve as Novartis copy delayed
Drugmaker GSK wins fresh Advair reprieve as Novartis copy delayed
LONDON (Reuters) – GlaxoSmithKline has won another reprieve for its blockbuster Advair lung drug after U.S. regulators delayed approval of a generic copy from Novartis’s Sandoz division.
The Swiss drugmaker said in an emailed statement on Thursday it had received a so-called complete response letter from the U.S. Food and Drug Administration (FDA) and a generic Advair launch this year was now “highly unlikely”.
Such letters from the FDA typically outline concerns and conditions that must be addressed to gain U.S. approval.
Reporting by Ben Hirschler; Editing by Edmund Blair