LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In November 2020

Olas Pharma
Olas Pharma

An FDA panel is slated to review privately-held Õlas Pharma Inc.’s New Drug Application for Hydexor on November 2, 2020.

Hydexor is proposed for the short-term (not to exceed 3 days) management of acute postoperative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting.

Hydexor, also known as CL-108, had been twice rejected by the FDA – in 2017 and in 2018.

It remains to be seen if Hydexor will be able to pass muster with the FDA at least this time.

Olas Pharma is the U.S. commercial subsidiary of Charleston Laboratories Inc., a specialty pharmaceutical company developing novel pain products that prevent or significantly reduce nausea and vomiting.