Strides Shasun receives USFDA tentative approval for Efavirenz Tablet

26 May 2016 Evaluate

Strides Shasun has received tentative approval from the United States Food & Drug Administration (USFDA) for Efavirenz Tablet USP, 600 mg. The final approval will be received after Patent Expiry in August 2018. Efavirenz Tablet is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents.

According to IMS data, the US market for Efavirenz 600 mg Tablet is approximately $150 million. The product will be manufactured at the company’s Oral dosage facility at Bangalore and marketed by Strides in the US market.

Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and and semi-solids.



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