Flamel Technologies (FLML) announced on Monday that the FDA has approved VAZCULEP (phenylephrine hydrochloride), the company’s alpha-1 adrenergic receptor agonist for the treatment of hypotension resulting from vasodilation. Phenylephrine is used quite frequently for low blood pressure during anesthesia.
Flamel will launch VAZCULEP 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 – 10 mg/mL. Fitting Flamel’s strategy of seeking approval for existing and unapproved products, phenylephrine is already on the market in approved and unapproved forms, though VAZCULEP is the only approved phenylephrine hydrochloride injection available in all three vial sizes. West-Ward Pharmaceuticals markets an approved version of the 1 mL vial, and Flamel says that one other company offers unapproved versions of the 5 mL and 10 mL bulk package vials, which were essentially ‘grandfathered’ approval in the mid-1900s.
Flamel expects that the FDA will remove these unapproved versions from the market within the next year or so, following FDA’s intended 1-year grace period, leaving Flamel as the sole provider of the higher-volume formulations.
