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Corporate - Regulatory Bodies & Rulings
USFDA nod for Strides' AIDS drug

Our Bureau

Bangalore March 28 Strides Arcolab has said it has received tentative USFDA approval for yet another anti-AIDS drug — Efavirenz tablets. The approval comes under the expedited review provisions of the US President's Emergency Plan for AIDS Relief programme.

Efavirenz is a generic version of Bristol-Myers Squibb's Sustiva, which prevents the AIDS virus from reproducing in cells. Efavirenz is used in combination with other anti-retroviral agents (ARVs) to treat HIV infections and is a key component of drug regimens for patients who are simultaneously being treated for tuberculosis.

Strides says it has ANDA/NDA (abbreviated new drug application) approvals for all first-line ARVs.

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