Log in | Register

E-mail
Company Name

FDA Extends Review Period for Eurand's ZENPEP(TM) Pancreatic Enzyme Replacement Therapy

Featured In: FDA

Monday, June 22, 2009

Share
Loading...
Eurand N.V., a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on proprietary pharmaceutical technologies, has announced that the FDA has advised the company that it has extended the June 2009 user fee goal date for the New Drug Application for ZENPEP(TM) (pancrelipase capsules) by three months.

The FDA did not request that the company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.

Join the Discussion
Rate Article:  Average 0 out of 5
register or log in to comment on this article!

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1

Blogs

The Importance of Fundamentals

The Importance of Fundamentals

Aug 31 | Girish Malhotra, PE, President, EPCOT International

Globally, Johnson & Johnson is known for its integrity and product quality. A few years ago they handled the Tylenol situation extremely well and were commended for it. It is astounding that the year 2010 has become a nightmare for them.  
The Quality Control Unit: Invertebrates Need Not Apply

The Quality Control Unit: Invertebrates Need Not Apply

Aug 30 | The QA Pharm

The Quality Control Unit (QCU) is the only pharmaceutical function that has a job description codified in the CGMP regulations. Don’t you find this remarkable? In fact, an entire section is devoted to describing the responsibility of the QCU and how it is to operate within the organization—namely independently.        

Multimedia

Timothy Cote - Office of Orphan Products Development

Aug 13 | Root

From approving medicines to treating snake bites to Cystic Fibrosis - Dr. Tim Cote describes a special office at the FDA, designed to address needs of people with rare diseases. Timothy Cote, M.D. - Director, Office of Orphan Products Development
Charles River Labs On WuXi PharmaTech Acquisition

Charles River Labs On WuXi PharmaTech Acquisition

May 25 | Video

Charles Rivers Laboratories International Chief Officer talks about the recent WuXi PharmaTech acquisition
Biogen Idec - 2010 Facility of the Year Award Winner - Operational Excellence

Biogen Idec - 2010 Facility of the Year Award Winner - Operational Excellence

Apr 27 | Video

Peter Flinn, Biogen Idec's Senior Director, Global Project Engineering talks to Pharmaceutical Processing's Editor-In-Chief Mike Auerbach about the company's Large-Scale Manufacturing Technology Map Project in Research Triangle Park, North Carolina. The project won the 2010 Operational...
MannKind Corporation - 2010 Facility of the Year Award Winner - Equipment & Process Innovation

MannKind Corporation - 2010 Facility of the Year Award Winner - Equipment & Process Innovation

Apr 28 | Video

Juergen Martens, Ph,D. MannKind Corporation's Corporate Vice President and Chief Technical Officer talks to Pharmaceutical Processing's Editor-In-Chief Mike Auerbach durng INTERPHEX2010 about the company's Technosphere Insulin Manufacturing Facility located in Danbury, Connecticut. The...