FDA Approves Flamel Technologies'NDA For VAZCULEP - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has approved Flamel Technologies (FLML)'s New Drug Application or NDA for VAZCULEP injection, for treating clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The company 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.

The firm said that the VAZCULEP is the only FDA-approved version of phenylephrine hydrochloride to be available in all three vial sizes, which will be of great convenience to hospitals and physicians.

Mike Anderson, Chief Executive of Flamel said: "...This is the second product from the portfolio of Unapproved Marketed Drugs products following the FDA approval of Bloxiverz in May 2013. Both of these drugs are used by anesthesiologists in hospital settings." "Based on our marketing experience, we believe that hospitals will welcome the addition of VAZCULEP as an FDA-approved version of phenylephrine hydrochloride in all vial sizes," he added.