Flamel Technologies (FLML) Announces U.S. Launch of Akovaz

August 12, 2016 7:52 AM EDT
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Flamel Technologies (NASDAQ: FLML) announced the launch of Akovaz™, its formulation of ephedrine sulfate for injection, which received approval from the U.S. Food and Drug Administration (FDA) on April 29, 2016. Ephedrine sulfate (50 mg/mL) is a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.

"I am pleased to announce the launch of Akovaz, the first version of ephedrine sulfate to be approved by the FDA. The market size of ephedrine sulfate is the largest yet from our portfolio of previously unapproved products. In total, we estimate the market volume to be somewhere in the range of seven million vials per year when factoring in sales to repackaging companies. There is currently one unapproved manufacturer of ephedrine sulfate with whom we expect to share the market," said Mike Anderson, Flamel's Chief Executive Officer.

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