SPARC, Sun Pharma get nod for SEZABY from USFDA

18 Nov 2022 Evaluate

Sun Pharma Advanced Research Company (SPARC) and Sun Pharmaceutical Industries have received approval from U.S. Food and Drug Administration (USFDA) for SEZABY (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.

SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures. SEZABY was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of SEZABY by the USFDA.

SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.

Sun Pharma Adv. Res Share Price

124.65 -4.70 (-3.63%)
23-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Syngene Internation. 542.55
Indegene 474.00
CMS Info Systems 319.15
Sagility 51.76
Smartworks Coworking 438.30
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×