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U.S. Department of Health and Human Services

For Consumers

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Approval of generic Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg

On April 6, 2010, the Food and Drug Administration granted approval for generic didanosine delayed-release capsules, 125 mg, 200 mg, 250 mg, and 400 mg, manufactured by Matrix Laboratories Limited, of Hyberdad, India. Although this Abbreviated New Drug Application (ANDA) was reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR), this represents a generic product approval, meaning that this product is eligible for sale in the United States.

Didanosine Delayed-release Capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

This approval means that FDA has found the generic formulations of to be bioequivalent and, therefore, therapeutically equivalent to Videx EC Delayed-release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg, respectively, made by Bristol Myers Squibb Company.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration