Strides receives tentative approval for Efavirenz

Strides Shasun announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for Efavirenz Tablet USP, 600 mg


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Efavirenz is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents.

The final approval will be received after Patent Expiry in August 2018.

According to IMS data, the US market for Efavirenz 600 mg Tablet is approximately USD $150 million.

The product will be manufactured at the company's oral dosage facility in Bangalore, and marketed by Strides in the US market.

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