ABSTRACT
To receive approval for an ANDA, applicants generally must demonstrate, among other things, that their product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is BE to the reference listed drug [21 USC 355(j)(2)(A); 21 CFR 314.94(a)]. BE drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient [21 USC 355(j)(8); 21 CFR 320.1(e)]. BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320.
