FDA Issues Final Rule on OTC Hand Sanitizers
The final rule states that certain active ingredients are not allowed to be used in OTC hand sanitizers, which are meant for use without water and soap.
All articles by Da Hee Han, PharmD
Esuberaprost Development Ends After PAH Trial Fails to Meet Primary Endpoint
United Therapeutics has decided to discontinue the development of esuberaprost for the treatment of PAH.
Ready-to-Administer Adenosine Simplist Syringes Now Available
Fresenius Kabi announced the launch of Adenosine Injection in single-dose Simplist ready-to-administer prefilled syringes.
FDA Issues Warning for Illegal Marketing of Pharmacogenetic Tests
The FDA issued a warning to Inova Genomics Laboratory for the illegal marketing of pharmacogenetic tests for predicting medication response to antidepressants, opioids, cancer therapy, anesthesia, and diabetes treatments.
FDA Provides List of Nitrosamine-Free ARB Medications
The FDA has released a list of 40 ARBs that do not contain any known nitrosamine impurities.
Empagliflozin Reduces Risk for Heart Failure Hospitalizations in Real-World Study
Boehringer Ingelheim and Lilly announced preliminary data from the EMPRISE ( EMPagliflozin compaRative effectIveness and SafEty) real-world study at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2019 in San Diego.
Canagliflozin sNDA Submitted for CV Risk Reduction in T2D With Chronic Kidney Disease
Janssen announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of end-stage renal disease and renal or cardiovascular (CV) death in adults with type 2 diabetes and chronic kidney disease.
ADA Updates Standards of Medical Care in Diabetes to Incorporate REDUCE-IT CVD Data
The American Diabetes Association (ADA) has updated the Standards of Medical Care in Diabetes for 2019 based on recently published research.
First Treprostinil Generic Now Available for Pulmonary Arterial Hypertension
Sandoz announced the launch of Treprostinil Injection, the first AP rated generic version of United Therapeutics’ Remodulin.
Rivaroxaban Reduces Post-Stroke Mortality Risk in Nonvalvular Afib
Rivaroxaban found to reduce risk of stroke.
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