Sandoz gets CRL for generic Advair

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year as planned after it received a complete response letter from FDA on its ANDA for the generic.

The delay offers temporary relief for GSK, whose 2018 growth projections are tied to generic Advair entry. In its FY17 earnings release on Feb. 14, the pharma said if a generic hits the U.S. market mid-year, it would expect 2018 adjusted EPS to remain flat or decline up to 3% over 2017 at constant exchange rates. In that scenario, GSK would expect Advair sales of about £750 million ($1.1 billion). If there are no generics this year, GSK expects adjusted EPS growth of 4-7% over 2017 EPS of 111.8p...