FDA Issues Draft Guidance to Help ANDA Sponsors Obtain Supplies of Brand Drugs

The Food and Drug Administration Dec. 4 released a draft guidance to help generic companies that are attempting to obtain approval of drugs subject to certain safety plans.

The guidance aims to assist in certain circumstances where brand-name drug companies refuse to sell supplies of reference listed drugs (RLDs) to prospective abbreviated new drug application (ANDA) sponsors.

Prospective ANDA sponsors need supplies of reference listed drugs to conduct bioequivalence studies and other testing to support their ANDAs, the FDA said in a statement on the draft guidance. Generic companies sometimes can’t obtain supplies of RLDs because the drugs are subject ...