SPARC dips on getting CRL from USFDA for Taclantis

Sun Pharma Advanced Research Company Limited (SPARC), on Tuesday, said that United States Food & Drug Administration (USFDA) has not approved its New Drug Application (NDA) for Taclantis, a product used for treating breast cancer.

SPARC has received a Complete Response Letter (CRL) from USFDA for Taclantis (Paclitaxel Injection Concentrate for Suspension). The company is reviewing the CRL, which is sent to a company when USFDA does not approve of a particular product. SPARC is planning to get in touch with USFDA soon to address the concern raised.

Earlier, Abraxis Biosciences LLC had dismissed the patent infringement complaint filed against SPARC regarding its NDA for Paclitaxel Injection Concentrate for Suspension (PICS).

SPARC had entered into an agreement in December 2019 with Bioprojet SCR (Bioprojet) to acquire its rights of SCD-044, an investigational medicinal product. The acquisition includes full assignment of all patents and related applications owned and controlled by Bioprojet related to SCD-044.

On Tuesday, the stock of SPARC had closed at Rs 191.15. On Wednesday, it opened gap down at Rs 184.35 and slipped 10.1 per cent to Rs 171.90 on BSE.