Press Release: Aspen Pharmacare Receives FDA approval for ARVs

Aspen Pharmacare announced today that it has received U.S. FDA approval for its co-packaged combination AZT/3TC+NVP. Aspen is the first generic pharmaceutical manufacturer to successfully receive approval by the FDA for ARVs in the most commonly used first-line regimen. It achieved approval via the expedited review process announced last May.

As part of the FDA review process, Aspen has undergone vigorous audits of its manufacturing plants, which confirmed Aspen's compliance with Good Manufacturing Practice (GMP), and its contract research laboratories, which confirmed the integrity of Aspen?s bioequivalence studies. The FDA also inspected manufacturing plants at both Hetero and Matrix, which supply Aspen with Active Pharmaceutical Ingredients (APIs) used in the final formulations.

Aspen continues to be an important supplier and partner of the Clinton Foundation, and we are pleased that the quality, safety and efficacy of its products have been reaffirmed by the FDA. Countries will be able to use PEPFAR, Global Fund, World Bank and bilateral funds to buy these FDA-approved products. Millions of people around the world need access to high-quality, affordable drugs. Today?s announcement reaffirms that high quality and affordability can go hand in hand. We applaud our partner, Aspen Pharmacare, for this achievement. The Clinton Foundation is proud to be partnering with Aspen.

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