FDA Wants More Information about AbbVie’s Parkinson’s TherapyMarch 22nd 2023
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
FDA Greenlights Generic Leukemia TreatmentMarch 10th 2023
Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.
FDA Grants Priority Review for Therapy for Life-threatening Hereditary Immune DiseaseFebruary 23rd 2023
If approved, pozelimab would be the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The target action date for the FDA decision is Aug. 20, 2023.