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The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company”s appeal of the Comprehensive Response Letter (CRL) in relation to the New Drug Application (NDA) for Taclantis, Sun Pharma Advanced Research Company (SPARC) stated in a regulatory filing.
In its letter, the OND asked the conduct of a new Phase 3 study in metastatic breast cancer patients to support any possible resubmission of their Taclantis NDA, it included.
The company is going to review FDA”s response and decide on appropriate next steps soon, SPARC noted.
As per the USFDA, a CRL 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 declared that the USFDA had accepted for review SPARC”s NDA for Taclantis.
The company”s NDA filing was based on successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data.
Abraxane is suggested for treatment of breast cancer, lung cancer, amongst others.
In 2017, USFDA had denied consent to SPARC”s new drug application for Elepsia XR, an anti-epileptic medication. PTI MSS ABM ABM
