New Delhi, Aug 14 (UNI) Bangalore-based pharma major Strides Arcolab Ltd today said it has received tentative approval from the US Food and Drug Administration for the key AIDS anti-retro viral drug -- 'Nevirapine' tablets 200mg.
The application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme, and this is the company's first ANDA approval.
''We are pleased to receive this first ANDA tentative approval from US FDA for Nevirapine Tablets. This approval represents significant opportunity for the company to commercialise Nevirapine -- a key anti-retro viral in the treatment of AIDS,'' Strides CEO and Vice Chairman Arun Kumar said.
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This ARV drug is used in combination with other ARV agents for the treatment of HIV-1 infection.
The company has four applications under review with the US FDA under the same programme and another four in the pipeline for submission. The company already has five WHO pre-qualified ARVs which are supplied to more than 37 countries in Africa and Asia.
Strides Arcolab is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.
UNI RA PV DS1230
The application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme, and this is the company's first ANDA approval.
''We are pleased to receive this first ANDA tentative approval from US FDA for Nevirapine Tablets. This approval represents significant opportunity for the company to commercialise Nevirapine -- a key anti-retro viral in the treatment of AIDS,'' Strides CEO and Vice Chairman Arun Kumar said.
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This ARV drug is used in combination with other ARV agents for the treatment of HIV-1 infection.
The company has four applications under review with the US FDA under the same programme and another four in the pipeline for submission. The company already has five WHO pre-qualified ARVs which are supplied to more than 37 countries in Africa and Asia.
Strides Arcolab is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.
UNI RA PV DS1230
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