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Biotech Stocks Facing FDA Decision In August

Egalet Corp
Egalet Corp

An FDA panel of outside experts is slated to review Egalet Corp.‘s (EGLT) new drug application for ARYMO ER extended-release tablets, an abuse-deterrent, oral morphine product candidate, on August 4, 2016.

The company is seeking approval of ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The FDA’s final decision is scheduled for October 14, 2016.

Last month, an FDA panel recommended two abuse-deterrent opioids namely Pfizer’s ALO-02 and Teva’s Vantrela ER for approval. ALO-02 and Vantrela ER are also intended for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.