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Sun Pharmaceutical’ Sezaby Receives the US FDA’s Approval for the Treatment of Neonatal Seizures

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Sun Pharmaceutical’ Sezaby Receives the US FDA’s Approval for the Treatment of Neonatal Seizures

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  • 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

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