Strides receives ANDA approval for Fosphenytoin

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New Delhi, Mar 19 (UNI) Pharmaceutical firm Strides Arcolab today said it has received its third ANDA approval for Fosphenytoin Injection 50mg/mL in two ml and 10 ml vials.

The product is licensed to Akom-Strides, LLC, which is a joint venture that was formed in 2004 by Akom and Strides Arcolab.

Fosphenytoin is the third approval amongst 22 sterile submissions it had submitted with the US FDA.

Fosphenytoin helps to control seizures (convulsions) in certain types of epilepsy and can help to prevent seizures occurring during or after surgery.

''We are excited with our third sterile injectable approval and are delighted having achieved a key milestone in creating a global sterile injectable business,'' company Vice Chairman and Group CEO Arun Kumar said in a statement.

The company plans to establish other areas of drug development, including API research, non-infringing process development, bio-technology research and establish clinical research capability in-house.


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