Sun Pharmaceuticals gets approval for Fosphenytoin Sodium Injection

Gujarat based drug maker, Sun Pharmaceutical Industries Ltd has 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.

The 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.

The drug is mainly used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery. The injection has annual sales of approximately $ 15 million in the United States.

Two days earlier, the company had received US FDA approval for marketing a generic version of Medimmune's Ethyol amifostine injection, used in the treatment of cancer.

Shares of the company gained Rs 1%, to end at Rs 1260. The total volume of shares traded was 407,821 at the NSE. (Wednesday)