ZymoGenetics Urged by FDA to Review Promotional Material of Recothrom
ZymoGenetics Inc., developer and manufacturer of therapeutic proteins, was told by the Food and Drugs Administration that its promotion of the treatment Recothrom had false and misleading material according to a letter released today.
In a press release sent by ZymoGenetics on January 17, the company suggested that Recothrom was safer than a competitor treatment. The U.S. regulator ruled that the statement excluded importatn contextual information necessary to understand the limitation of that finding.
Recothrom is a protein that helps to control surgical bleeding. ZymoGenetics added the information requested by the FDA on its promotional materials of the product.
A a spokeswoman for the company confirmed that the incident would not affect sales of the product which sold $1 million in the first quarter of its release, according to the companys financial report.
Shares of ZymoGenetics were up 2.94 percent to $8.42 on the Nasdaq in after hours trading on Wednesday.
© Copyright IBTimes 2024. All rights reserved.