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Aurobindo Pharma gets tentative nod for tablets to treat HIV-1

By Religare
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Manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, Aurobindo Pharma Ltd. has received the tentative approval from the US FDA to manufacture and market Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets in the strengths of 600mg/300mg/300mg.

The New Drug Application (NDA) 22-343 provides for the use of these tablets alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents aged over 16 years and weighting at least 40 kg, the company said in a filing to the Bombay Stock Exchange.

 

This NDA was reviewed under the President's Emergency Plan for AIDS Relief. The estimated ARV Access Market for the product is USD 120 million last year and expected to record strong growth in the coming year, the filing added.

Read more about: aurobindo pharma
Story first published: Friday, June 28, 2013, 22:57 [IST]
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