Sun Pharma gets USFDA approval for fosphenytoin sodium injection

Sun Pharmaceutical Industries has received USFDA approval for the abbreviated new drug application to market a generic of Parke Davis's Cerebyx, fosphenytoin sodium injection.

MUMBAI: Sun Pharmaceutical Industries has received USFDA approval for the abbreviated new drug application to market a generic of Parke Davis's Cerebyx, fosphenytoin sodium injection.

This fosphenytoin sodium injection USP, 50mg 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 $15 million in 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.

On Wednesday, Sun Pharma shares closed up 0.06 per cent at Rs 1,260.45 on BSE.
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