The FDA announces November 22 that orphan drug Nexavar (Sorafenib) receives approval for the treatment of patients with late-stage (metastatic) differentiated thyroid cancer. Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals.
FDA Regulatory Actions for Thyroid Cancer Indication
• In December 2011, receives Orphan Drug Designation (ODD)
• In August 2013, receives Priority Review for supplemental New Drug Application (sNDA)
• In November 2013, receives approval.
The FDA completes its review of Nexavar’s new indication under the agency’s Priority Review Program. A Priority Review designation means that the FDA will take action on a drug application within 6 months, as opposed to 10 months under standard review. If the drug in question is approved, then it will bring “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The FDA decides on the Priority Review designation…
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