LABA Label Changes Could Reinvigorate Single-Ingredient Products
FDA's new labeling and use guidelines for long-acting beta agonists may present some sales challenges, but also may create a new market for older drugs
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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.”
Possible contract from FDA would involve assessing whether PBM distribution of safety information to physicians would change prescribing practices.
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