Drug Pulled After FDA Threat on Research

Shire PLC has pulled its drug ProAmatine from the U.S. market after regulators threatened to withdraw approval. In a letter posted online August 16, the Food and Drug Administration said Shire had failed to do follow-up research. The FDA approved ProAmatine in 1996 to treat very low blood pressure. It based that decision on early research, but told Shire to do more studies to prove long-term benefits. Shire never submitted them. The FDA letter this week offered to discuss the matter at a hearing. Instead, Shire announced that it would remove the drug by the end of September, the Associated Press (AP) said. The FDA has the power to remove drugs when follow-up studies are not done. However, it has never done so. Shire’s decision does not completely remove the drug from the market. It is also sold as a generic drug, known as midodrine.