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news.Mylan, a generic pharmaceutical company, has announced that Matrix Laboratories, its India-based subsidiary in which it holds a 71.5% controlling interest, has received the first and only tentative approval from the FDA under the president's emergency plan for AIDS relief for its abbreviated new drug application for lopinavir/ritonavir tablets, 200mg/50mg.
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Matrix’s version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.
Lopinavir/ritonavir tablets are the generic version of Abbott Laboratories’s Kaletra tablets, the brand marketed in the US and Europe, and Aluvia tablets, the brand marketed in developing countries. It is used in combination with other medications to control HIV infection and is included in the antiretroviral class of drugs known as HIV protease inhibitors.
Robert Coury, vice chairman and CEO of Mylan, said: “With Matrix’s heat-stable and affordable version of lopinavir/ritonavir, patients in remote parts of developing nations will have access to this important life-saving drug. This is the second regulatory approval that this important product has recently earned, which further confirms our commitment to providing high-quality medicines at affordable prices.”