Pancreatic Insufficiency Drug Makers Given NDA Approval Deadline Of 2008
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is not removing unapproved products from the market because they are medically necessary. However, manufacturers must obtain approval of exocrine pancreatic insufficiency drugs within four years.
You may also be interested in...
Lilly's Pancreatic Enzyme Replacement Therapy Faces Advisory Committee Scrutiny
FDA's Gastrointestinal Drugs panel's Jan. 12 review of Solpura (liprotamase) is likely to focus on robustness of efficacy results and relevant endpoints.
Lilly's Pancreatic Enzyme Replacement Therapy Faces Advisory Committee Scrutiny
FDA's Gastrointestinal Drugs panel's Jan. 12 review of Solpura (liprotamase) is likely to focus on robustness of efficacy results and relevant endpoints.
Market Snapshot: Pancreatic Enzyme Products Get A Lift From FDA Rules
Specialty pharma Eurand's official launch of its pancreatic enzyme product Zenpep at the end of November marks the entry of the second product to meet tighter FDA standards required by 2010