FDA approves Solvay Pharmacueticals’ Creon

By Alaric Dearment

ROCKVILLE, Md. (May7) The Food and Drug Administration has approved a new drug for treating cystic fibrosis and exocrine pancreatic insufficiency, the agency announced Thursday.

The FDA approved Solvay Pharmacueticals’ Creon (pancrelipase), the first FDA-approved delayed-release pancreatic enzyme replacement drug to be marketed in the United States as a result of the agency’s unapproved drugs initiative.

The agency had required Solvay to submit a risk evaluation and mitigation strategy, including a medication guide, to advise patients on the risks associated with high doses of Creon. The FDA Center for Drug Evaluation and Research’s Office of Compliance and Office of New Drugs had worked with Solvay through the agency’s unapproved drugs initiative to help the company come into compliance with regulations by obtaining approval for Creon.

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