Shire decides to fight FDA's proposed withdrawal of ProAmatine
This article was originally published in Scrip
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 FDA's decision to seek withdrawal of the product. The company received a warning from the agency last month that inconclusive post-approval data threatened continued marketing authorisation.