Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- Allergan reaches $300 million settlement in pay-for-delay lawsuit
- California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause
- Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
- Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
- Pfizer announces introduction of three new biosimilars
- Coronavirus outbreak may affect the U.S. drug supply chain
FDA Approvals and Launches
- Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) is approved for the mitigation of allergic reactions due to peanut exposure in children.
- Reyvow (lasmiditan), a novel treatment for patients with acute migraines, launches at a list price of $640 per eight pills.
- Trijardy XR (empagliflozin/linagliptin/metformin) is approved to treat patients with type 2 diabetes.
- Ozempic (semaglutide) receives additional indication to reduce risk of major cardiovascular events in patients with type 2 diabetes and heart disease.
- Valtoco (diazepam) nasal spray is approved as an acute treatment for epilepsy.
- Ajovy (fremanezumab-vfrm) receives approval for administration through an auto-injector dose delivery system.