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FDA Sets Review Date for New COPD Drug, Anoro Ellipta

Approval decision expected in December (Feb. 19)

The FDA has accepted the new drug application (NDA) for an investigational once-daily LAMA/LABA combination medicine — umeclidinium bromide and vilanterol (UMEC/VI, GlaxoSmithKline/Theravance) — for patients with chronic obstructive pulmonary disease (COPD).

The Prescription Drug User Fee Act (PDUFA) goal date is December 18, 2013.

UMEC/VI — with the proposed brand name of Anoro — is a combination of two investigational bronchodilator molecules: umeclidinium bromide (formerly known as GSK573719, a long-acting muscarinic antagonist [LAMA]) and vilanterol (a long-acting beta2 agonist [LABA]). The combo drug is administered using the Ellipta inhaler.

Source: GSK; February 19, 2013.

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