February 8, 2012
FDA’s Center for Drug Evaluation and Research (CDER) and Shire have come to an agreement for Shire to conduct two additional clinical trials to verify the clinical benefit of the drug ProAmatine (midodrine HCL). While these trials are taking place, CDER’s proposal to withdraw approval of midodrine has been put on hold.
Should CDER determine that Shire has failed to adhere to the terms and timeframes in the joint agreement, as outlined in a December 2, 2011 letter to Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., or that the clinical trial results fail to verify the drug’s clinical benefit, Shire has agreed to have FDA withdraw approval of the New Drug Application for ProAmatine and to waive its opportunity for a hearing.
Midodrine remains FDA-approved and available in the marketplace.