SPARC on Tuesday said 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).
The company is reviewing the CRL and intends to work with the USFDA as soon as possible to address the concerns raised, it added.
Abraxane is indicated for treatment of breast cancer, lung cancer among others.
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 outlook, in 2018-19 annual report, SPARC said it has been successful in obtaining USFDA approvals for Xelpros and Elepsia XR in FY 2018-19. SPARC has filed NDA for Taclantis. SPARC expects to have an increase in royalty income with the licensing of Elepsia XR and Taclantis.