The Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Sun Pharma Advanced Research Company Ltd's appeal of the Complete Response Letter in relation to the New Drug Application (NDA) for Taclantis.

In its Appeal Denied letter, the OND requested the conduct of a new Phase 3 study in metastatic breast cancer patients to support any potential resubmission of the Taclantis NDA. The company will review FDA's response and decide on appropriate next steps soon.