Facts missing from ZymoGenetics press release
Pharma Compliance Alert, May 14, 2008
The FDA wants ZymoGenetics to revise a press release for the company’s first product, Recothrom, because important facts were omitted, according to an FDA warning letter.
In the press release, ZymoGenetics suggests Recothrom is safer than the bovine thrombin based on the results of a clinical trial. However, the FDA said the statement was misleading because it did not provide the context needed to understand the limits of the claim.
The FDA informed ZymoGenetics it was misbranding Recothrom and instructed the company to stop using the press release immediately.
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