FDA Approves New Hypotension Treatment

The FDA has approved Flamel Technologies’ new drug application for ephedrine sulfate (Akovaz), which is a drug administered parenterally to address hypotension in surgical settings.

Flamel Technologies intends to launch Akovaz during the third quarter of 2016 in a strength of 50 mg/mL.

"We are very excited to receive FDA approval for Akovaz, the third product from our Éclat portfolio, and in line with the PDUFA [Prescription Drug User Fee Act] date expectations,” said Mike Anderson, CEO of Flamel, in a press release. “Revenue expectations associated with this product were included in our previously issued 2016 revenue guidance of $110 to $130 million.”

Flamel is the first to receive FDA approval for ephedrine sulfate. However, there is one “unapproved marketed” formulation sold by Akorn Pharmaceuticals. IMS Health estimates the market size is more than 5 million vials annually.

Akovaz, an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent, must be diluted before it is intravenously delivered to patients.