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Regulatory Bodies & Rulings
Strides gets USFDA nod for AIDS drug Stavudine
Our Bureau
Bangalore
,
Aug. 29
Strides Arcolab said the USFDA has tentatively approved its abbreviated new drug application (ANDA) for AIDS drug Stavudine.
This is the company's second ANDA approval, this time for Stavudine capsules USP, 30mg and 40mg. The application was reviewed under the expedited review provisions of the US PEPFAR (President's Emergency Plan for AIDS Relief) programme.
Three more applications are awaiting approval under the same programme and another four are being readied for application. Strides said six of its ARVs (anti-retroviral agents used against AIDS) have received WHO pre-qualification for Asian and African markets.
Mr Arun Kumar, Vice-Chairman and CEO, said the approval means a big opportunity for Strides to commercialise Stavudine. The drug belongs to the class of NRTIs (nucleoside analog reverse transcriptase inhibitors), which prevent the virus from multiplying.
In addition, Strides also has a partnership with the Clinton Foundation to provide affordable generic ARVs in poor countries.
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