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FDA Rejects Depot Bupivacaine (Posidur) for Postoperative Pain Relief
Agency asks for additional safety studies (February 12)
The FDA has issued a complete response letter for Posidur (Saber–bupivacaine, Durect Corporation), an investigational drug for administration into the surgical site to produce postsurgical analgesia.
Based on its review of the product’s new drug application (NDA), the FDA determined that it cannot approve the application in its present form, stating that the NDA does not contain sufficient information to demonstrate that Posidur is safe when used in the manner described in the proposed label. The agency indicated that additional clinical safety studies need to be conducted.
Posidur is a postoperative pain-relief depot that utilizes patented Saber technology to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
Source: Durect Corporation; February 13, 2014.