Flamel Technologies Granted FDA Approval for VAZCULEP

Flamel Technologies (NASDAQ:FLML) has been granted approval of its New Drug Application by the U.S. Food and Drug Administration for VAZCULEP™ (phenylephrine hydrochloride). VAZCULEP™ is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

As quoted in the press release:

Flamel expects to launch VAZCULEP in the next few months in 1 mL single use vials, and 5 mL and 10 mL pharmacy bulk package vials. The drug strength is the same in all vials at 10 mg/mL. Phenylephrine hydrochloride is used in operating rooms and is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.

Flamel Technologies Chief Executive Officer, Mike Anderson, said:

We are extremely pleased to receive NDA approval for VAZCULEP from the FDA. This is the second product from the portfolio of UMDs (Unapproved Marketed Drugs) products following the FDA approval of Bloxiverz™ in May 2013. Both of these drugs are used by anesthesiologists in hospital settings.

Click here to read the Flamel Technologies (NASDAQ:FLML) press release