Sun Pharma arm- SPARC application for cancer drug Taclantis rejected by USFDA
"The company has received a Complete Response Letter (CRL) from the United States Food & Drug Administration (USFDA) for the new drug application (NDA) for Taclantis (Paclitaxel Injection Concentrate for Suspension)," Sun Pharma arm- SPARC said in a regulatory filing.
New Delhi: Sun Pharma Advanced Research Company (SPARC) on Tuesday said the US health regulator has not approved its new drug application for Taclantis, its underdevelopment product for the treatment of breast cancer.
"The company has received a Complete Response Letter (CRL) from the United States Food & Drug Administration (USFDA) for the new drug application (NDA) for Taclantis (Paclitaxel Injection Concentrate for Suspension)," SPARC said in a regulatory filing.
SPARC is reviewing the CRL and intends to work with the USFDA as soon as possible to address the concerns raised, it added.
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 last year, the company had announced that the USFDA had accepted for review SPARC's NDA for Taclantis.
The company's NDA filing was based on a successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data.
Abraxane is indicated for the treatment of breast cancer, lung cancer among others.
In 2017, USFDA had denied approval to SPARC's new drug application for Elepsia XR, an anti-epileptic drug.
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