Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Dasatinib | Sprycel | 4.4 Special Warnings and Special Precautions for Use | Hepatotoxicity | Feb,2023 |
Insulin Glargine/Lixisenatide | Soliqua Solostar | 4.4 Special Warnings and Special Precautions for Use | Cholecystitis, cholangitis, cholestatic jaundice | Feb,2023 |
Semaglutide | Rybelsus | 4.4 Special Warnings and Special Precautions for Use | Cholecystitis, cholangitis, cholestatic jaundice | Feb,2023 |
Isoniazid; Pyrazinamide; Rifampin | Rifater | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Thrombotic microangiopathy, haemolytic uremic syndrome | Feb,2023 |
Rifampicin | Rifadin | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Thrombotic microangiopathy , haemolytic uremic syndrome | Feb,2023 |
Human Normal Immunoglobulin | Hyqvia | 4.8 Undesirable effects | Updating pediatric data in undesirable effects | Feb,2023 |