Sun pharma and strides got approval to market generic version of Fosphenytoin. Fosphenytoin (Cerebyx®, Parke-Davis; Prodilantin®, Pfizer Holding France) is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. Fosphenytoin was approved by the USFDA on August 5, 1996 for use in epilepsy
Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised, such as endotracheal intubation, status epilepticus or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.
Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised, such as endotracheal intubation, status epilepticus or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.
Sun Pharma news
Sun Pharma 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 which 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.
Strides Arcolab news
Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials. The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc and Strides Arcolab Limited Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.
Strides Arcolab, one of India's largest exporters of branded generic pharmaceutical products, today announced its third ANDA approval for Fosphenytoin Injection 50mg/mL in 2 ml and 10ml vials. The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc and Strides Arcolab Limited Fosphenytoin is the third approval amongst 22 sterile submissions the Company has submitted with US FDA.
