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Endo passes US FDA approval of Ephedrine Sulfate Injection, USP.

M2 EQUITYBITES-January 31, 2017-Endo passes US FDA approval of Ephedrine Sulfate Injection, USP

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Pharmaceutical company Endo International plc (NASDAQ:ENDP) (TSX:ENDP) reported on Monday the receipt of final approval from the US Food and Drug Administration for its New Drug Application for ephedrine sulfate injection to address clinically important hypotension in surgical settings.

This US FDA approval has been awarded to the company's operating company, Par Pharmaceutical.

The company added that ephedrine sulfate injection is a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. Ephedrine sulfate for injection is packaged in cartons of 25, 50mg/ml, 1m. single use vials.

For the 12 months ended 30 November 2016, the US sales of the company's ephedrine sulfate injection products were approximately USD177m, according to IMS Health data.

In conjunction with the US FDA approval, the company expects to start shipping ephedrine sulfate injection in February 2017.

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Publication:M2 EquityBites (EQB)
Date:Jan 31, 2017
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