Sun Pharma’s arm receives USFDA approval for new label for Odomzo

20 Sep 2017 Evaluate

Sun Pharmaceutical Industries’ one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration (USFDA) for a new label for Odomzo (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Odomzo was approved by the USFDA in July 2015, based on 12-month follow-up results from the pivotal Phase II Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) clinical trial, a multicenter, double-blind study involving 194 patients with laBCC and 36 patients with metastatic basal cell carcinoma (mBCC).

Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.


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