New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday launched its phenobarbital sodium injection, SEZABY for the treatment of neonatal seizures in the US.
SEZABY is the first and only product approved by the US Food and Drug Administration (USFDA) for the treatment of neonatal seizures in term and preterm infants, Sun Pharma said in a regulatory filing.
It is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.
“The launch of SEZABY is an exciting addition to our growing portfolio of specialty branded products in the US,” Sun Pharma CEO North America Abhay Gandhi said.
He further said, “As the first and only FDA-approved product for the treatment of seizures in term and preterm infants, SEZABY has the potential to make a meaningful difference in the lives of patients and their families, and we are proud to be able to provide physicians with this new treatment option.”
Sun Pharma SEZABY was granted ‘orphan drug’ designation by the USFDA for the treatment of neonatal seizures.
Orphan drug designation is granted by the USFDA to medicine intended to treat a condition affecting fewer than 2 lakh persons in the US, or which will not be profitable within seven years following its approval.