GSK dodges bullet after another generic Advair competitor is denied

GlaxoSmithKline (NYSE:GSK) will not likely face generic competition to its lung drug Advair in the US this year. Yesterday, the FDA denied the application for a 2nd generic competitor. Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes on the heels of Mylan‘s (NSDQ:MYL) announcement in March that the federal watchdog delayed approval of its Advair generic. Thanks to these 2 rejections, industry analysts believe that the threat of generic competition has been pushed back until next year, according to Reuters.  Get the full story at our sister site, Drug Delivery Business News. The post GSK dodges bullet after another generic Advair competitor is denied appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Hikma Pharmaceuticals PLC Mylan Source Type: news