Sun Pharma Advanced Research Company Ltd. on Tuesday said the U.S. Food and Drug Administration ruled against its appeal related to Taclantis, its under-development product for treating breast cancer.
The Office of New Drugs of the U.S. FDA has denied the company's appeal of the complete response letter in relation to the new drug application for Taclantis, SPARC said in a regulatory filing.
In its letter, the regulator requested conducting a new Phase 3 study in metastatic breast cancer patients to support any potential resubmission of the Taclantis applicaton, it added.
The company will review FDA's response and decide on appropriate next steps soon, SPARC noted.
As per the U.S. FDA, a complete response letter is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form.
On July 1, 2019, the company had announced that the U.S. FDA had accepted for review SPARC's application for Taclantis.
The company's filing was based on successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data.
Abraxane is indicated for treatment of breast cancer, lung cancer, among others.
In 2017, U.S. FDA had denied approval to SPARC's new drug application for Elepsia XR, an anti-epileptic drug.
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