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news.The US Food and Drug Administration (FDA) has granted tentative approval under the President's Emergency Plan for AIDS Relief (PEPFAR) for Matrix Laboratories,' subsidiary of Mylan, new drug application (NDA) for Abacavir Sulfate tablets, 60mg.
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Abacavir Sulfate tablets are used in combination with other medications to control HIV infection and is included in the ARV class of drugs known as nucleoside reverse transcriptase inhibitors.
Mylan claims that the tablet is a preferred form because it provides ease, accuracy and convenience of dosing over the currently available oral solutions.
The pediatric dosage in tablet form was developed by Matrix for use in treating children with HIV/AIDS.
Mylan president Heather Bresch said that the approval is particularly important because it adds to the available treatment options for children who are living with HIV/AIDS in developing countries.
"The addition of Abacavir to Mylan and Matrix’s HIV/AIDS antiretroviral (ARV) franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs," Bresch said.