Drug firm Aurobindo Pharma today said it has received tentative approval from the US health regulator to manufacture and market efavirenz,lamivudine and tenofovir disoproxil fumarate tablets used for treating a type of HIV infection.
The company has received the tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg,a statement by Aurobindo Pharma said.
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The new drug application (NDA) provides for the use of tablets alone or in combination with other antiretrovirals 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
This NDA was reviewed under the President’s Emergency Plan for AIDS Relief (PEPFAR),Aurobindo Pharma said.
“The estimated ARV access market (Emerging Markets) for the product was USD 120 million last year and is expected to record strong growth in the coming year,” it added.
Aurobindo now has a total of 191 abbreviated new drug application (ANDA) approvals (163 final approvals including 4 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
Shares of Aurobindo Pharma were today trading at Rs 178.50 per scrip on BSE,up 1.02 per cent from its previous close.