FDA guidance for prospective ANDA sponsors

The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances where brand-name drug companies refuse to sell to prospective Abbreviated New Drug Application (ANDA) sponsors supplies of reference listed drugs (RLDs).

Prospective ANDA sponsors need supplies of reference listed drugs to conduct bioequivalence (BE) and other testing to support their ANDAs, the FDA explains.

The problem of generic companies’ inability to obtain reference listed drug supplies can arise where the drug product is not available through regular distribution channels because it is subject to distribution restrictions (imposed either through a Risk Evaluation and Mitigation Strategy [REMS] or voluntarily by the RLD holder).