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USFDA accepts Sun Pharma’s application for Tildrakizumab

The US Food and Drug Administration (USFDA) has accepted Sun Pharmaceutical Industries’ Biologics License Application (BLA) for tildrakizumab. The USFDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017.

Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA.

Sun Pharmaceutical Industries is an Indian multinational pharmaceutical company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.


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