Strides Arcolab receives NDA approval from USFDA

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Strides Arcolab receives NDA approval from USFDA

Strides Arcolab receives first NDA approval from USFDA

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Strides Arcolab Ltd.  today announced that it has received tentative approval from the United States Food and Drug Administration for Lamivudine/Zidovudine 150 mg/300 mg Tablets co-packaged with Nevirapine 200 mg Tablets.

This is the company's first NDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief [PEPFAR] program.

Arun Kumar - Vice Chairman and Managing Director, Strides Arcolab said "We are pleased to receive our first tentative approval for a NDA from the USFDA. This approval represents a significant opportunity for Strides to commercialize field adaptable fixed dose combination ARVs co-packaged with other ARVs for ease of patient compliance."

The company has already received tentative approval from FDA for Stavudine Capsules and Nevirapine Tablets. Four applications are under review with the US FDA under the same program and another 12 are in the pipeline for development and submission. The company has 6 WHO pre-qualified ARVs which are supplied to more than 37 countries in Africa and Asia.

The company is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.

Sourced From: Adfactors Public Relations Pvt Ltd