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Corporate - Regulatory Bodies & Rulings
Strides gets nod for 2 NDAs

Our Bureau

Bangalore, March 14

Strides Arcolab has said it has received tentative USFDA approvals for two more anti-HIV NDAs (new drug applications). This takes the total NDAs/ANDAs (abbreviated NDA) approvals received to eight.

The latest approvals are for fixed dose combination of lamivudine/ stavudine 150 mg/40 mg tablets; and lamivudine / stavudine 150/40 mg tablets co-packaged with Nevirapine 200 mg tablets, an official release said. Both were approved under the expedited review provisions of the PEPFAR (President's Emergency Plan for Aids Relief) programme. Mr Arun Kumar, Vice-Chairman and MD of Strides Arcolab, said the two new approvals were key products in the treatment of HIV and would provide a boost to Strides' TB and malaria initiative.

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