Phenobarbital Injection is a current standard of care for treatment of neonatal seizure. Existing marketed product is not approved by US FDA which means it is not reviewed by US FDA for safety, effectiveness or quality. This marketed product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with “Gasping Syndrome” in neonates and low-birth weight infants.
SPARC has developed preservative-free injection of Phenobarbital for treatment of neonatal seizure and this product received Orphan Drug Designation by US FDA for treatment of neonatal seizure in October 2019.
FDA granted fast track designation for Phenobarbital Sodium for Injection on August 4th, 2021. In compliance with Section 561A(f)(2) of the FD&C Act, SPARC is providing public notification that an Expanded Access Program is not available for Phenobarbital Sodium for Injection at this time