Shire decides to fight FDA's proposed withdrawal of ProAmatine
This article was originally published in SRA
Executive Summary
Plans by Shire to withdraw its hypotension drug, ProAmatine (alpha 1-agonist midodrine hydrochloride), have been put on hold as the company has revealed plans to appeal the US Food and Drug Administration's decision to seek withdrawal of the product1. The company received a warning from the agency last month that inconclusive post-approval data threatened continued marketing authorisation.