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Home » Gilead Loses Appeal to FDA for Cystic Fibrosis Antibiotic
Gilead Loses Appeal to FDA for Cystic Fibrosis Antibiotic
February 20, 2009
Gilead Sciences was unsuccessful in overturning a decision by the FDA’s Division of Anti-Infective and Ophthalmology Products requiring the company to conduct an additional clinical study for its antibiotic aztreonam lysine before the agency will approve the drug.