Flamel Technologies (NASDAQ: FLML) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. Flamel obtained NDA approval for Akovaz as scheduled on April 29 and is the first to receive approval from the FDA for ephedrine sulfate. Flamel expects to launch Akovaz during the third quarter 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 date expectations. Revenue expectations associated with this product were included in our previously issued 2016 revenue guidance of $110 - $130 million. Our Éclat portfolio of products, which includes Bloxiverz® and Vaculep®, has produced significant cash flow for Flamel, allowing us to operate independently of partners, fund strategic acquisitions and continue development of our proprietary pipeline products," said Mike Anderson, Chief Executive Officer of Flamel.
Currently, there is one "unapproved marketed" formulation of ephedrine sulfate 50 mg/mL injection sold by Akorn Pharmaceuticals, and according to IMS Health, the market size is over five million vials per year.
Akovaz is the brand name for the Company's ephedrine sulfate injection, USP, an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Akovaz injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) must be diluted before administration and is injected intravenously as a bolus.