A wholly-owned subsidiary of Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd., announced the signing of a licensing agreement for commercialization of benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the United States. SPARC submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for this product for the treatment of neonatal seizures in February 2022. Currently, there are no phenobarbital injection products approved by the US FDA for the
treatment of seizures in newborns.
Under the terms of the license agreement, Sun Pharma will pay SPARC an upfront payment of US $10 million. SPARC will also be eligible to receive milestone payments contingent upon the achievement of regulatory and sales milestones, as well as tiered royalties on sales.
