The United States Food and Drug Administration (FDA) has announced tentative approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories and Aurobindo Pharma Limited, both based in India. These are the first generic versions of nevirapine tablets to be approved for purchase by the President's Emergency Plan for AIDS Relief (PEPFAR).
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTIs) used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The use of single dose nevirapine for the prevention of mother to child transmission of HIV is permitted under PEPFAR.
Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.
In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.
A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).
How well something works (in a research study). See also ‘effectiveness’.
The FDA's tentative approval means that although existing patents and/or exclusivity prevent the marketing of Aurobindo's and Ranbaxy's products in the United States, these products meet all of the agency's quality, safety and efficacy standards required for marketing in the United States. Therefore, they are eligible to be considered for purchase and use outside the United States under the PEPFAR program.
