SPOTLIGHT -
What you need to know about the FDA’s most recent novel drug approvals.
NDA for Investigational Schizophrenia Treatment Submitted to FDA
The NDA was submitted for investigational muscarinic antipsychotic, KarXT (xanomeline-trospium), which functions as a dual M1/M4 muscarinic acetylcholine receptor agonist within the central nervous system.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
First Anti-Inflammatory Drug for Cardiovascular Disease Approved by FDA
Lodoco (colchicine) approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022.
FDA Approves Sotagliflozin For Heart Failure Across Full Range of LVEF
The medication is broadly approved for heart failure with preserved or reduced ejection fraction.
FDA Approves First Oral Treatment for Patients With Moderate to Severe Crohn's Disease
The approval of Rinvoq (upadacitinib) was based on the results of three clinical trials: two induction therapy studies and one maintenance study.
FDA Approves Two Medications for Treatment of Schizophrenia
Otsuka America Pharmaceutical and Lundbeck’s Alify Asimtufii (aripiprazole) also was approved for maintenance monotherapy treatment of bipolar I disorder in adults.
