Comparability protocol for 22.5 mg tablets (NADA # 141-526)

Anivive Lifesciences, Inc, Long Beach CA

Investigators

Abstract

Project Summary/Abstract The protocol is to add an additional strength of Laverdia tablets. Successful execution of this protocol will result in the addition of a 22.5 mg tablet to the existing portfolio of 2.5 mg, 10 mg and 50 mg tablets. There will be no changes to the manufacturing process or facility currently approved for Laverdia tablets. Approved analytical procedures will be used to assess and test the new tablet strength.