Sun Pharma and SPARC sign a licence contract for the sale of phenobarbital

Sun Pharma Advanced Research Co. and Sun Pharmaceutical Industries Ltd. Ltd (SPARC) reported on Wednesday that the businesses had signed a licencing agreement for the commercialization of phenobarbital for injection in the US.

In February 2022, SPARC submitted a New Drug Application (NDA) for this medicine to the US Food and Drug Administration (USFDA). The USFDA has not yet approved the formulation, which is intended to treat neonatal infants who are experiencing seizures.

The goal of the phenobarbital sodium powder for injection without propylene glycol and benzyl alcohol is to reduce the danger of neonatal gasping syndrome, a condition that can be fatal. The USFDA has not yet approved any phenobarbital injectable medicines for the management of infantile spasms.

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