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Biotech Stocks Facing FDA Decision In March

Endo International plc
Endo International plc

On March 13, 2017, the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee are scheduled to discuss safety issues of Endo International plc’s (ENDP) Opana ER.

Opana ER was approved by the FDA in 2006 for patients requiring continuous, around-the-clock opioid treatment for an extended period of time. A new formulation of Opana ER designed to be crush-resistant received FDA approval in December 2011.

In June 2015, the Centers for Disease Control and Prevention blamed the reformulated Opana ER for an outbreak of HIV in southern Indiana.

Net sales of Opana ER in the nine months ended September 30, 2016 declined to $120.05 million from $132.16 million in the comparable year-ago period.