The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated new drug application (ANDA) proposed generic drug products compared with the reference listed drug (RLD).
FDA defines an active ingredient as one “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.” An active ingredient “may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect,” the agency said.
Demonstrating that an active ingredient contained in a proposed generic drug product is the same as an RLD is required when submitting the product through ANDA. FDA recommended applicants use the same active ingredient in the proposed drug product and the RLD and “fully evaluate the potential for changes in or to the active ingredient during the manufacturing process.”…
