US FDA begins safety review of LABA asthma drugs

10 March 2008

The US Food and Drug Administration has requested information from makers of long acting beta-2 agonist (LABA) drugs, which are used to treat asthma. According to a Reuters report, the agency plans to convene a panel of experts in the fall to asses the safety of LABAs in children and adults. Products under scrutiny include Anglo-Swedish drug major AstraZeneca's Symbicort (budesonide/formoterol) and UK-based giant GlaxoSmithKline's Seretide/Advair (fluticasone propionate/salmeterol). On the day of the news, March 3, shares in GSK closed down 2.6% to L10.56. The London-headquartered firm could be affected if safety restrictions are implemented as the drug is its top earner, netting L3.5 billion ($6.9 billion) in full-year 2007 (Marketletter February 18).

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