FDA rejects Mylan ’ s Advair generic in win for GSK

Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects to wait until it receives the full notice on June 27 to determine how the rejection will impact its 2018 financial outlook. Get the full story at our sister site, Drug Delivery Business News. The post FDA rejects Mylan’s Advair generic in win for GSK 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 Mylan Novartis Source Type: news