Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA EXOCRINE PANCREATIC INSUFFICIENCY DRUGS WORKSHOP

Executive Summary

FDA EXOCRINE PANCREATIC INSUFFICIENCY DRUGS WORKSHOP will be held on April 23 to discuss testing procedures that will be required for NDAs for all OTC digestive aids for cystic fibrosis and chronic pancreatitis patients. The workshop will begin at 8:30 a.m. in conference rooms D & E at FDA's Parklawn Building in Rockville, Md. The idea of holding a workshop was suggested by FDA at a Nov. 26 meeting with the Cystic Fibrosis Foundation at which the parties discussed FDA's July 15, 1991 proposal that all exocrine pancreatic insufficiency products be considered new drugs requiring an approved NDA for continued marketing ("The Pink Sheet" Dec. 2, 1991, T&G-2). FDA also proposed that the products be available only by prescription. The agency is concerned that a pancreatic drug's formulation and manufacturing process may affect its safety and efficacy and believes that the issue can be best addressed under the NDA review process. Topics that will be considered at the workshop include design of studies "to show that the drugs provide and deliver the enzyme content that is declared on the container labeling and that the stated activity is released in the intestine to show that the drug will have bioactivity," a March 11 Federal Register notice announcing the meeting states. Workshop participants will discuss the appropriate study populations for these studies. FDA posed the following questions for consideration at the meeting: "Do cystic fibrosis patients have to be used in the studies, or can the needed information be obtained using normal volunteers?" and "Is it possible to use patients with other pancreatic insufficiency problems?" Other issues for the workshop are study endpoints, enzyme measurement, manufacturing controls, reference standards, dissolution rates, and enzyme content and labeling. Marketed OTC pancreatic enzyme drugs include: Hoechst- Roussel's OTC Festal II (the company also markets an Rx Festal), A. H. Robins' Donnazyme, Entozyme, Entolase and Viokase, McNeil's Pancrease, Organon's Cotazym and Zymase, Solvay's Creon and Vitaline's Pancreatin. FDA is reopening the administrative record for the OTC rulemaking for these products until July 23 to allow submission of comments resulting from the workshop.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL005491

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel