Arcolab Ltd has announced having received tentative approvals
from the US Food and Drug Administration for two new drug
applications (NDA) for fixed dose combination of Lamivudine
/ Stavudine 150mg / 40 mg Tablets and Lamivudine / Stavudine
150 / 40mg tablets co-packaged with Nevirapine 200mg Tablets.
drugs were approved under the expedited review provisions
of the 'president's emergency plan for aids relief' (PEPFAR)
programme. This takes the total NDAs / ANDAs approvals
received to 8 under the PEPFAR program.
Kumar, vice chairman and managing director, Strides Arcolab,
said "the two new NDA approvals being key products
in the treatment of HIV will provide a fillip to our Aids,
TB and Malaria
Company also partners the Clinton Foundation to ensure
availability of affordable quality generic ARVs in least