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Journalism of Courage
Ranbaxy Laboratories Ltd (Ranbaxy) and Aurobindo Pharma have received a ‘‘tentative approval’’ from the US Food and Drug Administration (US FDA) for an anti-HIV/AIDS drug.
The approval is for Nevirapine, a generic version of Boehringher Ingelhiem’s Viramune tablets, used in combination with other retro-viral drugs. The tentative approval means the drug meets FDA norms for efficacy, safety and quality, and can be part of the US President’s ‘PEPFAR’ program to supply low-cost AIDS drugs to the poorest and developing countries.
Tentative clearance also means that the existing patents and exclusivity rights will not allow the firms to market their drug in the US, though it meets all regulatory approvals. They can market these drugs elsewhere.
‘‘These are the first generic versions of Viramune tablets manufactured by Boehringer Ingelheim. These products will now be available for consideration for purchase under the President’s Emergency Plan For Aids Relief (PEPFAR),’’ an FDA release said on Tuesday.
