FDA Panels Favor Advair, Symbicort Over Single-Entity LABAs For Asthma
Three FDA advisory committees recommended the withdrawal of asthma indications for two long-acting beta agonists - GlaxoSmithKline's Serevent (salmeterol) and Novartis's Foradil (formoterol) -during a Dec. 11 meeting
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FDA says Novartis’ assessment of the long-acting beta agonist’s REMS, which consisted only of a communication plan, shows the “plan, and therefore the REMS, has met its goal.”
When a post-marketing safety signal arises, patients’ perspective of benefit is often drowned out by consumer advocates’ worries about a drug’s risks, the Office of New Drugs director says.
Symbicort's rapid onset of action and lack of pneumonia signal could be competitive advantages as the drug enters the market with its newly approved use for chonic obstructive pulmonary disease