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THRX > SEC Filings for THRX > Form 8-K on 20-Sep-2013All Recent SEC Filings

Show all filings for THERAVANCE INC



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Item 8.01. Other Events

On September 20, 2013, GlaxoSmithKline plc (GSK) and Theravance, Inc. issued a press release announcing that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved RELVAR(TM) ELLIPTA(TM) for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required). Relvar Ellipta is not indicated for the treatment of chronic obstructive pulmonary disease in Japan. Relvar is a combination of the inhaled corticosteroid, fluticasone furoate "FF", and the long-acting beta2 agonist, vilanterol "VI". The MHLW has approved two doses of FF/VI - 100/25 mcg and 200/25 mcg. Both strengths will be administered using the Ellipta, a new dry powder inhaler. FF/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc. A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference. Item 9.01. Financial Statements and Exhibits

(d) Exhibits
99.1 Press Release dated September 20, 2013

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