Flamel Technologies today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for VAZCULEP (phenylephrine hydrochloride). VAZCULEP Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. 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.
"We are extremely pleased to receive NDA approval for VAZCULEP from the FDA," said Mike Anderson, Chief Executive Officer of Flamel. "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."
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. One other company has an FDA-approved version of the 1 mL single use vials. Based on our knowledge, there is another company that offers unapproved versions of phenylephrine hydrochloride, but only in the 5 mL and 10 mL pharmacy bulk package vials. These unapproved versions have been on the market as grandfathered products under the Food, Drug and Cosmetic Act of 1938.
"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," continued Mr. Anderson