Mylan receives WHO Prequalification for generic Sovaldi

First generic prequalification for sofosbuvir tablets.

Mylan's Sofosbuvir Tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program. With WHO PQ approval, international donors and purchasers, such as UNITAID and UN agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy. "This marks another important step in Mylan's leadership to help fight infectious diseases around the world," commented Mylan President Rajiv Malik. "It also furthers our mission of increasing access to high quality, affordable medicines to patients, healthcare practitioners, governments and other stakeholders to help treat hepatitis C." Worldwide, there are more than 70 million people living with chronic hepatitis C, which results in nearly 400,000 related deaths every year. WHO estimates that antiviral medication can cure more than 95% of chronic hepatitis C cases.