Shots:

• The US FDA has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures with an expected availability in the US in Q4’23
• The approval was based on the results from the P-II (NEOLEV2) study evaluating levetiracetam vs phenobarbital in 94 neonates with neonatal seizures. Patients treated with levetiracetam were seizure-free (73% vs 25%) after 24hrs.
• SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection & marks the first product for neonatal seizures in term and preterm infants in the US. The therapy received ODD from the US FDA for the same indication

Ref: Sun Pharmaceutical | Image: Sun Pharmaceutical