LABA Safety Studies, REMS Are Next Topics For Sponsors, FDA After Relabeling
Discussions about how best to study the safety of long-acting beta agonists are ready to resume now that FDA has issued a revised label for the drug class
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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.”
The trials, which follow a label change and new REMS, will encompass seven times the patients included in the studies submitted to FDA for approval.
Given the known risks of long-acting beta-2 agonists, a safety discussion seems likely when the Pulmonary-Allergy Drugs Advisory Committee meets to review Novartis' Arcapta Neohaler (indacaterol maleate).