Pancreatic Enzyme Product Activity Steps Up As NDA Deadline Approaches
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
With the NDA submission deadline for previously unregulated pancreatic enzyme products less than a year away, the exocrine pancreatic insufficiency market is heating up as manufacturers of pig-derived products seek to stay on the market and a non-porcine alternative noses closer to submission
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What's That Drug Called?
The trade name of Alnara Pharmaceuticals' liprotamase for exocrine pancreatic insufficiency has suffered a fate in many ways similar to what happened to the application itself at the advisory committee: it's been knocked around a bit by FDA and others.
What's That Drug Called?
The trade name of Alnara Pharmaceuticals' liprotamase for exocrine pancreatic insufficiency has suffered a fate in many ways similar to what happened to the application itself at the advisory committee: it's been knocked around a bit by FDA and others.
This Little Pig-Free Product Goes To Market? Alnara's High Hopes For A PERT
Alnara claims its latest trial shows real-world effectiveness of liprotamase, formerly called Trizytek, and plans early 2010 NDA.