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# FDA Denies Sun Pharma Taclantis CRL Appeal
- URL: https://www.fdaweb.com/fda-denies-sun-pharma-taclantis-crl-appeal/
- Published: 2021-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:48:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148742

FDA has denied Sun Pharma’s appeal of the complete response letter the agency issued for Sun’s NDA for Taclantis (PICS), a novel formulation of paclitaxel under development to treat breast cancer. India’s *Economic Times* [reports](https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-rules-against-sun-pharma-advanced-research-cos-appeal-regarding-cancer-drug-application/articleshow/81174716.cms?ref=fdaweb.com) that FDA asked the company to conduct a new Phase 3 study in metastatic breast cancer patients to support any resubmission of the NDA. The company said it will review the response and decide on the next steps.