FDA’s Move to Withdraw Drug Shows Tougher Stance on Postapproval Studies

August 17, 2010
Signaling a tougher approach toward drugmakers that fail to complete their postapproval studies, the FDA is taking steps to withdraw a low blood pressure drug that has been on the market for 14 years. If the FDA’s proposal to take midodrine HCl off the market is successful, it would be the first time the agency has withdrawn a drug due to failure of a drugmaker to live up to its commitment to postmarket studies, FDA spokeswoman Sandy Walsh said. The drug — marketed as ProAmatine by Shire and as a generic by Apotex, Impax, Mylan, Sandoz and Upsher-Smith — received accelerated approval in 1996.
Drug Industry Daily