The two 12-month studies published in The Lancet demonstrated that roflumilast produced a statistically significant and clinically relevant reduction in exacerbations (lung attacks that need treatment with systemic steroids or lead to hospitalisation), ev * Yellowish skin coloring
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Practice technology profile and professional resources, including electronic prescribing and EMR The pooled data for lung function using the pre-bronchodilator FEV1 measurement (forced expiratory volume in one second) showed an average increase of 48mL (p<0.
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The FDA * Pregnant women with gestational hypertension, or women experiencing certain pregnancy related complications (toxemia of pregnancy) appear to have an increased risk
Exacerbations are frightening events resulting in increased patient anxiety, worsening health status, lung function decline and increased risk of death.
* Luteinizing hormone (LH)
* Bosentan because liver problems may occur; the effectiveness of both medicines may be decreased
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions.
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