GENEVA PETITIONS FDA TO RELIST ABBOTT HYTRIN TABLETS IN "ORANGE BOOK"; SOMERSET ASKS AGENCY TO DENY NOVOPHARM PETITION TO RELIST ELDEPRYL TABLETS
Executive Summary
Geneva was filed a petition with FDA requesting that the agency relist Abbott's Hytrin tablets in the "Orange Book" and declare that Abbott did not withdraw the NDA for the tablet formulation of the alpha blocker for reasons of safety and efficacy.