TOPICAL GENERIC DRUG EXCIPIENTS CAN BE DIFFERENT FROM REFERENCE

Executive Summary

TOPICAL GENERIC DRUG EXCIPIENTS CAN BE DIFFERENT FROM REFERENCE listed drug, a recent FDA Office of Generic Drugs memorandum on its interim inactive ingredients policy explains. "All excipients in a topical drug product are considered to be exception excipients" for which Title I of the Waxman-Hatch Act "allows changes from the reference listed drug," the memo states. The memo from OGD Acting Director Doug Sporn to Associate Director for Science and Medical Affairs Roger Williams summarizes OGD's interim inactive ingredient policy for filing and approving ANDAs for parenteral, ophthalmic, otic and topical generic drugs.