Strides Arcolab Receives Tentative FDA Approval For Efavirenz Under PEPFAR Review Process

Indian pharmaceutical company Strides Arcolab on Wednesday announced that it has received tentative FDA approval for the tablet form of its generic antiretroviral drug Efavirenz under the expedited review guidelines of the President's Emergency Plan for AIDS Relief, PTI/The Hindu reports (PTI/The Hindu, 3/28). The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by organizations outside the U.S. under PEPFAR (Kaiser Daily HIV/AIDS Report, 8/2/06). Efavirenz is the generic version of Bristol-Myers Squibb's Sustiva (PTI/The Hindu, 3/28). The drug is used in combination therapies, as well as in drug regiments for people on concurrent treatment for tuberculosis. Arun Kumar, Strides Arcolab's vice chair and managing director, said that the tentative FDA approval "will give [a] major boost to our AIDS, TB and malaria initiative, particularly in Africa and South Asian countries" (Strides Arcolab release, 3/28).