Sun Pharmaceutical Industries informs about approval for NDA

21 Dec 2018 Evaluate

Sun Pharmaceutical Industries has informed that the U.S. Food and Drug Administration (USFDA) has granted approval for the New Drug Application (NDA), to a wholly owned subsidiary of the company, for ElepsiaTM XR 1000 mg (levetiracetam 1000 mg) and ElepsiaTM XR 1500 mg (levetiracetam 1500 mg). This product was filed from the company’s  Halol (Gujarat, India) facility. The company’s wholly owned subsidiary had in-licensed ELEPSIATM XR from Sun Pharma Advanced Research Company  (SPARC) in July 2016.

The above information is a part of company’s filings submitted to BSE.

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