The United States Food and Drug Administration (USFDA) has recently approved the new drug application of Strides Arcolab for the antiepileptic Fosphenytoin injection. The officials of the Strides Arcolab have informed the news and said that the approval for Fosphenytoin is the third approval among the 22 sterile submissions or ANDAs, that the company has already made to the US regulator.
According to one of the top officials of the company, the formulation of 50 mg/ml is available in 2-ml and 10-ml vials and the Akorn- Strides, LLC, is holding the license for it. The company is actually a Joint Venture between the Akorn, Inc and Strides and it was formed in thje year of 2004. While commenting on the issue, the Vice-Chairman and Group CEO of Strides Arcolab, Mr. Arun Kumar said that the approval is a key milestone in creating a global sterile injectable business.
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| Posted : 3/21/2008 |
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