FDA approved Onzetra Xsail (Avanir Pharmaceuticals Inc.)— a fast-acting, low-dose sumatriptan dry powder formulation for the acute treatment of migraine with or without aura in adults.
Glycopyrrolate bromide is a quick-onset long-acting muscarinic antagonist bronchodilator with FDA approval for use as maintenance treatment of COPD. Seebri Neohaler is approved for use at a dose of 15.6 ug inhaled twice daily.
There is a growing group of LAMA/LABA combination therapies in development. Investigations into the risks and benefits of LAMA/LABA therapy have demonstrated benefits.
FDA has approved mepolizumab for adjunctive maintenance treatment of severe asthma in patients 12 years of age and older with markers of eosinophilic asthma.
Because of concerns about adverse effects, training through the Addyi REMS program is required for prescribers and pharmacies that want to participate in the medication use process for this drug.
Patients taking Pradaxa had no option for anticoagulation reversal; it was this unmet medical need that caused FDA to grant idarucizumab accelerated approval.
