The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.
Similar Posts
Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall.Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019
Task Description Request Please post to the ORA Electronic Reading Room
Record Date 12/20/2019
Short Title (70 char) Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019
FEI Number 3013341563
Firm Name Fusion IV Pharmaceuticals, Inc.
Record Type AmeANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsClinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
CDER Clinical Outcome Assessments (COA) Qualification Program: Frequently Asked Questions (FAQs)Nonprescription Drugs Advisory Committee Roster
This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee.Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.