Sun Pharma gets US FDA approval to market generic Cerebyx
20 Mar 2008
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Mumbai: Sun Pharmaceutical Industries Ltd has received approval from the US Food and Drug Administration (US FDA) to market Fosphenytoin sodium injections.
Fosphenytoin is a generic variant of Pfizer Inc's Cerebyx.
Cerebyx is a water-soluble phenytoin prodrug used in hospitals for the treatment of epileptic seizures during neurosurgery. Cerebyx vial contains 75 mg / ml fosphenytoin sodium, hence it is referred as a fosphenytoin sodium injection. Cerebyx is a clear, colourless to pale yellow, sterile solution.
Fosphenytoin sodium injections has annual sales of $15 million in the US, Sun Pharma said in a statement.
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