Posted by Michael Wonder on 11 May 2017
GSK escapes Advair hit for now as second generic bid fails
11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United States this year, after a second application for a cut-price equivalent form of the medicine was turned down by U.S. regulators.
Industry analysts believe the generic threat has now been pushed back until mid-2018, providing Britain's biggest drug maker with a short-term profit boost.
Hikma Pharmaceuticals said on Thursday the FDA had decided not to approve its version of the inhaled treatment for asthma and chronic lung disease at this time, due to "major" issues with the application.
