Aurobindo Pharma Receives Tentative FDA Approval to Produce Chewable Tablets of Generic Antiretroviral Didanosine for PEPFAR

FDA has granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce a chewable tablet form of the antiretroviral drug didanosine, Iris.com reports (Iris.com, 7/12). Didanosine is a generic version of Bristol-Myers Squibb's VIDEX, which was FDA-approved in December 2004. The drug is used in combination with other antiretrovirals for the treatment of HIV-1 infection (Kaiser Daily HIV/AIDS Report, 12/6/04). The tentative approval allows Aurobindo to produce the drug in strengths of 100mg, 150mg and 200mg. This is the first time FDA has tentatively approved a generic version of didanosine in chewable tablet form (Iris.com, 7/12). 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 relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief (Kaiser Daily HIV/AIDS Report, 7/3).

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