Matrix Laboratories Ltd, the Indian subsidiary of Mylan Inc of the US, has received tentative approval for its abbreviated new drug application (ANDA) Lopinavir and Ritonavir tablets 200/50 mg from the US Food & Drug Administration (USFDA) under the president`s emergency plans for AIDS relief (PEPFAR), the company said in a filing with the Bombay Stock Exchange (BSE).
The drug is used in combination with other medications to control HIV-1 infection and is included in the anti-retrovial (ARV) class of drugs known as HIV protease inhibitors.
The drug, which provides the first affordable protease inhibitor for patients in developing countries, complements recent WHO approval earned for the same product, Mylan said in its release
Mylan Inc, which holds a 71.5 per cent controlling interest in Matrix Laboratories, said Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.
"Mylan and Matrix are committed to our growing and high quality antiretroviral franchise. Our goal is to provide HIV treatments to patients around the world - especially in developing countries. 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," Mylan vice chairman and CEO Robert J Coury said.
Lopinavir/Ritonavir tablets are the generic version of Abbott Laboratories' 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 (ARV) class of drugs known as HIV protease inhibitors.
Last month, Matrix was awarded the first and only WHO approval for the same product.
Matrix, whose wide range of ARV products includes active pharmaceutical ingredients (API) and first- and second-line finished doses, has approximately 30 per cent of the HIV/AIDS drugs.
Mylan Inc markets products to customers in more than 140 countries and territories.