FDA Approves Sun Pharma’s Fosphenytoin Sodium Injection
March 20, 2008
Sun Pharmaceutical Industries has announced that the FDA has granted approval for the abbreviated new drug application to market fosphenytoin sodium injection.
Fosphenytoin sodium injection USP, 50mg PE/mL, is therapeutically equivalent to Parke Davis’s Cerebyx, and is available in two packs: 100mg PE/ 2mL and 500mg PE/10mL single dose vials.
Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery. This product will reach the market shortly.