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Gilead Moves Closer to US Approval of Cystic Fibrosis Treatment

By Pharmaceutical Processing | December 11, 2009

FOSTER CITY, Calif. (AP) — Gilead Sciences Inc. said Thursday an advisory committee has recommended U.S. approval of the biotechnology company’s inhalable cystic fibrosis treatment candidate. The company said the Anti-Infective Drugs Advisory Committee of the Food and Drug Administration recommended that aztreonam be approved. The drug is aimed at treating chronic lung infections caused by the bacterium Pseudomonas aeruginosa. Gilead has said those lung infections are the biggest killer of people with cystic fibrosis. The FDA is not required to follow the recommendation of its advisory committees, though it normally does. The FDA set a target review date of Feb. 13 for the drug candidate. The drug is already conditionally approved in Canada and the European Union under the trade name Cayston.

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