Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP

Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its New Drug Application for ephedrine sulfate injection, a drug administered parenterally as a pressor agent to address clinically important hypotension in...

Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its New Drug Application for ephedrine sulfate injection, a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. According to IMS Health data, U.S. sales of ephedrine sulfate injection products were approximately $177 million for the 12 months ended November 30, 2016.

Ephedrine sulfate for injection is packaged in cartons of twenty-five 50mg/mL, 1mL single use vials.  Par expects to start shipping the product in February 2017.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated (5.1)
  • Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis (5.2)

ADVERSE REACTIONS
Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. 

About Endo International plc
Endo International plc (NASDAQ / TSX: ENDP) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications through its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA.

Source: phx.corporate-ir.net