FDA Supersizes Its Order For LABA Safety Studies
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
US FDA concludes that combination products do not increase risk of serious asthma-related events compared to inhaled corticosteroids alone.
FDA approves GlaxoSmithKline’s LABA/inhaled corticosteroid combo for asthma in adults but says more data needed in adolescents. GSK plans to throw additional promotional support behind the existing pediatric asthma claim for Advair, which is expected to face generic competition in the coming years.
The long-acting beta agonist olodaterol cleared FDA for treatment of chronic obstructive pulmonary disease, but it didn’t gain the differentiating claim the German pharma was seeking.