The FDA has issued letters to eight pharmaceutical manufacturers and 12 distributors warming them to stop marketing and distributing 20 unapproved ergotamine tartrate medications used to treat Migraine attacks and vascular headaches.
Steven Galson, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) said,
"Unapproved drugs pose real risks to the American public... Because they have not been subject to FDA review, the safety, effectiveness, and quality of such ...
