March 19, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection.
This fosphenytoin sodium injection USP, 50 mg PE*/ mL, is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents).
Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US.
Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery.
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