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Published on 20 March 2008

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FDA approves fosphenytoin sodium injection

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The US Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) for fosphenytoin sodium injection USP, 100 mg/2mL and 500 mg/10mL (equivalent to phenytoin sodium).

Fosphenytoin sodium injection is a prodrug of phenytoin sodium, and is indicated for short-term use in the prevention and control of generalised seizures occurring during neurosurgery.

The drug is administered parenterally, and as a prodrug, metabolises into the active metabolite phenytoin sodium.

This version of the drug is manufactured by a joint venture, funded equally by Akorn, Inc and Strides Arcolab. Acorn manufactures and markets sterile speciality pharmaceuticals, and is based in the US. Strides Arcolab Ltd is one of India’s largest exporters of branded generic pharmaceutical products, with an number of manufacturing sites across the US, Brazil, Mexico, Italy, Poland, Singapore and India.

The joint venture’s portfolio also includes 29 ANDAs and 53 product line offerings.

In a statement given by Arthur S Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC, he said: “We are excited to announce this product approval for Fosphenytoin Sodium Injection.”

FDA



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