FDA OKs AIDS Drugs for Use Abroad

Published Online: Saturday, October 1, 2005

The FDA has given tentative approval for a series of new generic AIDS drugs to be manufactured by 2 pharmaceutical companies in India. This move will open the door for lower-priced treatments to become available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) in developing countries.

Although none of the new generics will be marketed in the United States because of existing patent restrictions, the FDA's tentative approval means that they meet rigorous US standards for quality, safety, and efficacy. These are prerequisites for drugs provided to AIDS patients in impoverished foreign countries under the PEPFAR.

Aurobindo Pharma Ltd of Hyderabad, India, will manufacture generic versions of the following drugs:

  • The nucleoside reverse transcriptase inhibitor (NRTI) Epivir (lamivudine) and the combination NRTI drug Combivir (lamivudine and zidovudine), produced by GlaxoSmithKline (GSK)
  • The nonnucleoside reverse transcriptase inhibitor (NNRTI) Viramune (nevirapine), manufactured by Boehringer Ingelheim
  • The NNRTI Sustiva (efavirenz) and the NRTI Zerit (stavudine), produced by Bristol-Myers Squibb

Ranbaxy Laboratories Ltd of Guragon, India, also will produce a generic version of Viramune, as well as GSK's NRTI Retrovir tablets (zidovudine 300 mg).

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