Food and Drug Administration - March 9, 2007
Richard Klein, Kimberly Struble

This is a generic version of the already FDA approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured by Bristol Myers Squibb.

FDA granted tentative approval for this product on October 5, 2006, permitting purchase of this generic formulation of didanosine by the President's Emergency Plan for AIDS Relief, or PEPFAR. A tentative approval means that a drug product has met FDA's safety, efficacy and quality standards, but is ineligible for marketing in the U.S. until patent and/or exclusivity restrictions expire.

However, because patents and exclusivity for Videx For Oral Solution have expired (see FDA's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the " Orange Book"), the generic formulation can be granted approval, allowing it to be marketed in the United States.

Didanosine for Oral Solution is approved for use in combination with other antiretroviral agents in the treatment of HIV infection.

I thought this would be an excellent example to illustrate the relationship of FDA to the President's Emergency Program for AIDS Relief. The PEPFAR program was created to provide government funding to treat, and reduce transmission of HIV in 15 focus countries, mostly in Sub-Saharan Africa, but including Haiti, Guyana, and Vietnam.

Because drugs that do not conform to standards of potency, purity, stability, or good manufacturing procedures may pose a threat by increasing chance of substandard performance, treatment failure, and emergence of resistant virus, PEPFAR limits funding to acquire only products that have undergone stringent regulatory review.

While FDA does not approve drugs for use in other countries, the agency has expedited review procedures in place (and conducts inspections of the manufacture and testing sites) to determine whether the drug products meet FDA safety, efficacy, and manufacturing quality standards, thus making them eligible for purchase using PEPFAR funds.

When the determination is made that a product meets the required criteria and standards, FDA may issue a "tentative approval," even though the product cannot yet be marketed in the U.S. because of legal restrictions related to existing exclusivity rights held by the original drug manufacturer. Once marketing exclusivities expire, FDA can grant marketing approval of the generic formulation in the U.S. market.

Since the time didanosine for oral solution received a tentative approval in October 2006, allowing it to be purchased through PEPFAR (for use in PEPFAR-affected countries), expiration of patents has resulted in an approval that now allows marketing of this generic formulation of didanosine for oral solution in the United States.

Richard Klein | Office of Special Health Issues | Food and Drug Administration

Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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