Sun Pharmaceuticals Industries and Sun Pharma Advanced Research Company today 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 US 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
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