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Aurobindo Pharma Ltd has received the tentative approval to manufacture and market Efavirenz Lamivudine Tenofovir Disoproxil Fumarate tablets from the US Food & Drug Administration (US FDA).
The drug is indicated for the treatment of HIV-1 infection in adults and adolescents aged more than 16 years of age and weighing at least 40 kg. It can be used alone in combination with other anti-retroviral (ARVs).
The New Drug Application (NDA) for the drug as reviewed under the President’s Emergency Plan for AIDS Relief of the US, the Hyderabad-based company said in a release.
The estimated ARV Access Market (Emerging Markets) for the product was $120 million last year and was expected to record strong growth in the coming year, it added.
Aurobindo’s scrip gained 1.05 per cent in the pre-noon session on the Bombay Stock Exchange on Friday and was trading at Rs 178.55.
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