SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): December 14, 2012
(Exact Name of Registrant as Specified in its Charter)
(State or Other Jurisdiction of
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Item 8.01 Other Events.
On December 14, 2012, the Office of the Federal Register published a Federal Register Notice that on March 7, 2013 the U.S. Food and Drug Administrations Pulmonary-Allergy Drugs Advisory Committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline (GSK), for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. Fluticasone furoate and vilanterol, an investigational once-daily inhaled corticosteroid/long-acting beta2 agonist (LABA) combination treatment, is in development under the LABA collaboration between GSK and Theravance, Inc.
The Federal Register Notice on the advisory committee can be found at http://www.gpo.gov/fdsys/pkg/FR-2012-12-14/pdf/2012-30171.pdf.