When Approvable Is Good News: Forest Gets January Launch for Bystolic
This article was originally published in RPM Report
Is there a way out of the woods for new drug sponsors seeking FDA approval for products with broad primary care indications? Forest may have found a path with nebivolol, but the formula is not one that will excite many other drug sponsors.
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Approval letters are down, "approvable" and "non-approvable" letters are up. "Black box" warnings have seen a four-fold increase over the last five years. Biopharma executives are now drawing their own conclusions about the state of FDA regulation-based on the numbers.
Wyeth has had some tough times with FDA on its current crop of NDAs.Those experiences sent a team of senior execs down to FDA to find out what is up at the agency. What the execs heard was a call to action. The meeting "caused us at Wyeth to realize that we have to find a different way to operate." The current series of delays and rejections for important new drug applications is not a temporary situation for companies to ride out, but rather a sign of new regulatory