labels: pharmaceuticals
Strides Arcolab gets tentative US FDA nod for AIDS drug news
29 March 2007

Mumbai: Strides Arcolab Ltd announced on Wednesday that it has received tentative approval from the United States Food and Drug Administration (US FDA) for Efavirenz tablets under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme.

Efavirenz, the generic version of Bristol Myers Squibb's Susvita, is a non-nucleoside reverse transcriptase inhibitor, which prevents the AIDS virus from reproducing in cells. Efavirenz is used in combination with other anti-retroviral agents for the treatment of HIV-infections and is a key component of drug regimens for patients who are on concurrent treatment for tuberculosis.

"We now have ANDA/NDA approvals for all first line anti-retroviral drugs. This will give major boost to our AIDS, TB and Malaria (ATM) initiative particularly in Africa and South Asian countries," Arun Kumar, vice chairman and managing director of the company, said.

The company also partners the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.

The company recently obtained tentative approvals from the USFDA for two new drug applications for fixed dose combination of Lamivudine/Stavudine tablets in the strength of 150/40 mg and Lamivudine / Stavudine q50/40 mg tablets co-packaged with Nevirapine 200 mg tablets, both under the expedited review provision of the President's Emergency Plan for aids relief programme.

Strides Arcolab Ltd is an exporter of branded generic pharmaceutical products. The company employs around 1,700 people across the globe and has a marketing presence in over 50 countries.

The company posted consolidated profit after minority interest and share from associates of Rs 40 crore on total income of Rs760 crore.


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Strides Arcolab gets tentative US FDA nod for AIDS drug