Strides Shasun receives tentative nod from USFDA for HIV drug Efavirenz

Strides Shasun on 26 May 2016 announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for Efavirenz tablets USP, 600 mg.

The final approval will be received after patent expiry in August 2018. The company will manufacture the product at its oral dosage facility in Bengaluru.

About Efavirenz

• Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI).

• It is used as part of Highly Active Antiretroviral Therapy (HAART) for the treatment of a Human Immunodeficiency Virus (HIV) type 1.

• It is also used in combination with other antiretroviral agents as part of an expanded postexposure prophylaxis regimen to reduce the risk of HIV infection in people exposed to a significant risk.

• It was discovered at Merck Research Laboratories.

• It is on the WHO Model List of Essential Medicines, the most important medication needed in a basic health system.

About Strides Shasun

• Strides Arcolab is an Indian pharmaceutical company, headquartered at Bangalore in southern India.

• The company manufactures pharmaceutical products, over-the-counter drugs and nutraceuticals.

• The company has 15 manufacturing sites in six countries and marketing presence in 50 countries.

• The company's stock trades on the Bombay Stock Exchange and on the National Stock Exchange of India.

• Strides Arcolab changed name to Strides Shasun Ltd after an amalgamation of Shasun Pharmaceuticals with Strides Arcolab.

• Arun Kumar is the founder and Group CEO, and has been on the Board as Managing Director since its inception.

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