Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications
The purpose of this guidance is to assist manufacturers of exocrine pancreatic insufficiency drug products in preparing and submitting new drug applications (NDAs). On April 28, 2004 (69 FR 23410), the Food and Drug Administration (FDA) announced that all orally administered pancreatic enzyme products (PEPs) are new drugs that will be approved for prescription use only, and explained the conditions for continued marketing of these drug products. This guidance pertains to products that contain the ingredients pancreatin and pancrelipase; these ingredients, which are of animal origin, contain the following enzymes: lipases, proteases, and amylases. These enzymes break down fats (lipases), proteins (proteases), and carbohydrates (amylases) into elementary units of small size that can traverse the intestinal mucosa, incorporate into the blood stream, and work as sources of energy and building blocks of cells.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.