Mylan Pharmaceuticals has launched the generic version of Sofosbuvir 400mg tablets under the brand name of MyHep in India.
The product has been developed to treat chronic hepatitis C, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen.
The disease is said to affect around 100 million people in the developing worldwide, including around 12 million people in India.
Mylan president Rajiv Malik said: "The launch of Mylan’s MyHep offers hope to millions of hepatitis C patients in India who are in need of a high-quality, effective and affordable treatment option.
"We look forward to bringing that same hope to millions of more hepatitis C patients as we expand access to MyHep in the developing world."
In September 2014, Mylan signed a licensing and technology transfer agreement with Gilead, which enabled it to receive the non-exclusive rights to manufacture and distribute generic Sofosbuvir in 91 developing countries, including India.
Mylan said that MyHep will be sold as part its Hepato Care segment, which is expected to enhance its commercial business in India.
Mylan Pharmaceuticals also sells products in four other segments, including critical care, HIV care, women’s care and oncology.
Earlier this month, Mylan also launched Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.8mg/0.025mg and Ferrous Fumarate Tablets, 75mg (chewable), in the US. It is the generic version of Warner Chilcott’s Generess Fe Tablets.
Mylan’s partner Famy Care obtained approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for this product, which is indicated to prevent pregnancy in women who elect to use oral contraceptives as a method of contraception.
Image: Mylan’s generic Sofosbuvir 400mg tablets. Photo: courtesy of Mylan NV.