FDA advisory committees recommend approval of esketamine nasal spray for treatment-resistant depression

Cross-posted from our Optum Insights blog. Two advisory committees of the U.S. Food and Drug Administration (FDA) recently voted to approve esketamine nasal spray for the treatment of adults with treatment-resistant depression (TRD), which is typically defined as failing trials of at least two antidepressant treatments for major depressive disorder. Esketamine is chemically related to … Read moreFDA advisory committees recommend approval of esketamine nasal spray for treatment-resistant depression

FDA approves first generic of Advair Diskus® inhaler for asthma and COPD

This content is crossposted from our Optum Insights blog. The U.S. Food and Drug Administration (FDA) has approved the first generic version of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). Mylan is the first company to obtain FDA approval to market its generic inhaler. Advair Diskus, manufactured by GlaxoSmithKline, received its FDA approval in … Read moreFDA approves first generic of Advair Diskus® inhaler for asthma and COPD

FDA creates faster way to access over-the-counter naloxone products to treat opioid overdoses

The following is cross-posted from our Optum Insights—Government Affairs blog The U.S. Food and Drug Administration (FDA) recently established a more rapid path for pharmaceutical companies to add over-the-counter (OTC) naloxone products to the market to increase access to naloxone – a life-saving medication used for the emergency treatment of opioid-related overdose – and help … Read moreFDA creates faster way to access over-the-counter naloxone products to treat opioid overdoses

Lyrica® generic delayed until summer 2019 and Pfizer to increase drug prices

This is a cross-post from our Optum Insights blog. The U.S. Food and Drug Administration’s (FDA) recent decision to grant pediatric exclusivity for Lyrica® ― as it may be used as an adjunctive therapy for partial onset seizures in pediatric epilepsy patients ― extends the period of market exclusivity in the U.S. by an additional … Read moreLyrica® generic delayed until summer 2019 and Pfizer to increase drug prices