FDA Updates Guidance on Pharmaceutical Co-Crystals


The FDA Aug. 16 released an updated draft guidance to help drug manufacturers classify pharmaceutical co-crystals.

The draft guidance provides information to manufacturers planning to submit new drug applications and abbreviated new drug applications on the appropriate regulatory classification of pharmaceutical co-crystals and the data that applicants should submit to support that classification, the Food and Drug Administration said.

Co-crystals are crystalline materials composed of two or more different molecules in the same crystal lattice, the FDA said. Pharmaceutical co-crystals can enhance drug product stability and make it easier to process active pharmaceutical ingredients.

The agency said its new guidance is based on feedback from entities affected by a previous guidance, from 2013.

A notice announcing the draft guidance was published in the Aug. 17 Federal Register (81 Fed. Reg. 54,808). Comments on the draft guidance, identified by Docket No. FDA-2011-D-0800, are due Oct. 17.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center. Learn more about Bloomberg Law and sign up for a free trial.