Another fast-track drug is under FDA scrutiny. The Shire blood-pressure drug ProAmantine won agency approval in 1996 under its accelerated approval process. But follow-up studies required by that program--to confirm that it was really as effective as billed--were never conducted, the agency says.
Now, 14 years later, it's not only the branded version that will be affected by a withdrawal. Mylan Pharmaceuticals, Impax Laboratories, Novartis' generics unit Sandoz, Apotex and Upsher-Smith Laboratories would have to stop selling their generic copies, too.
The FDA's potential withdrawal isn't exactly a surprise to these companies, as the Wall Street Journal notes; last year, the Government Accountability Office actually mentioned ProAmantine when it scolded FDA for failing to follow up on drugs approved on the fast track. Since then, the agency wrote to Shire and the generics makers, requesting two studies to confirm the drugs' benefits. No studies materialized, the FDA says.
ProAmantine is the third fast-tracked drug to hit the FDA spotlight. Pfizer pulled its cancer drug Mylotarg in June after post-marketing studies raised new safety concerns and failed to confirm its effectiveness. And Roche's cancer drug Avastin is under scrutiny after new studies raised questions about its fast-tracked approval for breast cancer use.
- get the FDA's release
- read the WSJ story
- get more from Reuters
- see the Boston Business Journal article