Propeller Health announced the FDA cleared its Propeller platform to market in association with medications using GlaxoKlineSmith’s Diskus dry powder inhaler device for asthma and chronic obstructive pulmonary disease (COPD). The clearance follows 510(k) clearance to market the Propeller platform in association with medications using Boehringer Ingelheim’s Respimat inhaler for COPD received in March 2015.
GlaxoSmithKline plc (GSK) and Theravance, Inc. today announced that the New Drug Application (NDA) for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 12 th May 2013.
GlaxoSmithKline plc and Theravance, Inc. announced today that following approval by Theravance, Inc.'s stockholders at their Annual Meeting held on 15 May 2012, and expiration of applicable waiting periods under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976, GSK's acquisition of 10,000,000 shares of Theravance common stock on the terms previously announced on 2 April 2012, has now completed.
As a result, GSK now owns 25,814,421 shares of Theravance common stock, approximately 26.7% of the total outstanding capital stock of Theravance.