Monday, April 18, 2011

FDA orders safety studies for some asthma drugs | Reuters

U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca's Symbicort, GlaxoSmithKline's Advair Diskus, Merck & Co's Dulera, and Novartis AG's Foradil.


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