FDA Releases Final Guidance On Information for Scored Drug Tablets

The Food and Drug Administration announced guidance on what information needs to be included in a new drug application or abbreviated new drug application for drug tablets that have been scored, which allows tablets to be split for smaller dosages.

In a notice published March 13 in the Federal Register (78 Fed Reg. 15,956), FDA announced the guidance, Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. The guidance provides recommendations to sponsors of NDAs and ANDAs regarding what criteria should be met when evaluating and labeling tablets that have been scored, the notice said. A ...