FDA gives OK to Akovaz to treat hypotension crisis in surgical setting


The FDA has approved Flamel Technologies’ ($FLML) Akovaz for the treatment of hypotension in the event of a crisis during a surgical procedure.

Akovaz (ephedrine sulfate) is the first to receive the regulatory agency’s approval of the drug for such use, the company said. The drug is typically indicated in the treatment of allergic disorders such as bronchial asthma. Flamel officials said they expect to launch Akovaz in the form of 50 milligram does in the third quarter this year.

The injectable drug is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of a significant reduction in blood pressure that might occur while a patient in under anesthesia. 

Hypotension is one of the most common intraoperative crisis incidents during surgery and has been associated with devastating perioperative complications, such as stroke and myocardial infarction.

Mike Anderson, CEO of Flamel, said in a statement that revenue expectations for Akovaz that were previously issued in its fiscal guidance for the year are in the range of $110 million to $120 million

- here’s Flamel’s release
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