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Sun Pharma Advanced Research Company informs about FDA approval

21 Dec 2018 Evaluate

Pursuant to regulation 30 of the SEBI (Listing Obligation & Disclosure Requirements) Regulations, 2015, Sun Pharma Advanced Research Company has informed that US Food and Drug Administration (USFDA) has approved the New Drug Application (NDA) of ElepsiaTM XR 1000 mg (levetiracetam 1000 mg) and ElepsiaTM XR 1500 mg (levetiracetam 1500 mg). ElepsiaTM XR was filed from Sun Pharmaceutical Industries Halol (Gujarat, India) facility. SPARC had out-licensed ELEPSIATM XR to a wholly owned subsidiary of Sun Pharmaceutical Industries Limited in July 2016.

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