India’s Ranbaxy Laboratories has announced that seven of its antiretroviral products have been reinstated to the World Health Organization’s list of prequalified antiretrovirals (ARVs) after new bioequivalence tests carried out by `globally recognised` contract research laboratories.
Three Ranbaxy products were taken off the list last year after discrepancies in record-keeping came to light that were traced to contract research organisations that had carried out the original tests proving the company’s generic antiretrovirals were equivalent to the originator, or branded, products.
Ranbaxy voluntarily removed a further eight products in order to check the bioequivalence in November 2004.
Last week Ranbaxy said that the following products have been added to the WHO prequalification list:
- Lamivudine 150mg+Nevirapine 200mg+Stavudine 40mg tablets
- Lamivudine 150mg+Nevirapine 200mg+Stavudine 30mg tablets
- Lamivudine 150mg+Stavudine 40mg tablets
- Lamivudine 150mg+Stavudine 30mg tablets
- Lamivudine 150mg+Zidovudine 300mg tablets
- Lamivudine 150mg tablets
- Zidovudine 300mg tablets
Three of these products have already received `tentative approval` from the US Food and Drug Administration, which means that they can be purchased with funds made available through the President’s Emergency Plan for AIDS Relief (PEPFAR) in fifteen countries where the United States is funding a major expansion of ARV treatment.
The return of Ranbaxy’s fixed dose products to the WHO prequalification list is likely to widen the choice available to treatment programmes wishing to follow the WHO recommendation that fixed dose ARV products combining two or three of the drugs used in triple combination therapy should be used wherever possible in resource-limited settings.