FDA approves the first generic naloxone nasal spray to treat opioid overdoses

Cross-posted from Optum Insights blog. On April 19, the U.S. Food and Drug Administration (FDA) approved the first generic for Narcan® Nasal Spray, the life-saving medication used for the emergency treatment of opioid-related overdose. After receiving tentative approval last June, Teva Pharmaceuticals USA Inc. has been granted final approval to market naloxone nasal spray. Teva … Read moreFDA approves the first generic naloxone nasal spray to treat opioid overdoses

FDA requires label changes for opioid analgesics to guide prescribers when gradual tapering is needed

This is a crosspost from the Optum Insights blog. The U.S. Food and Drug Administration (FDA) issued a safety communication in early April that requires changes to prescribing information for opioid analgesics used in outpatient settings. The goal is to expand the information available to health care providers and patients when opioid analgesics have been … Read moreFDA requires label changes for opioid analgesics to guide prescribers when gradual tapering is needed

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