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COPYRIGHT 2003 International Medical News Group
GAITHERSBURG, MD. -- The majority of a Food and Drug Administration expert panel recommended against the approval of a novel treatment for chronic obstructive pulmonary disease, citing the need for longer studies.
In a 7-to-3 vote, the FDA's Pulmonary-Allergy Drugs Advisory Committee agreed that efficacy and safety data on cilomilast, a phosphodiesterase-4 (PDE-4) inhibitor, did not provide "substantial and convincing evidence" to support approval. Taken orally twice a day, cilomilast is thought to have anti-inflammatory effects in patients with chronic obstructive...
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