Labopharm Submits Complete Response For Tramadol
This article was originally published in The Pink Sheet Daily
Executive Summary
Canadian specialty pharma now awaits new action date for delayed once-daily analgesic, already launched in 12 other countries.
You may also be interested in...
FDA Denies Gilead’s Appeal Of Aztreonam Lysine “Complete Response” Letter
Gilead has not yet discussed with FDA whether ongoing studies will be sufficient for resubmission of the inhaled antibiotic for use by cystic fibrosis patients.
FDA Denies Gilead’s Appeal Of Aztreonam Lysine “Complete Response” Letter
Gilead has not yet discussed with FDA whether ongoing studies will be sufficient for resubmission of the inhaled antibiotic for use by cystic fibrosis patients.
Labopharm Gets January Action Date For Once-Daily Tramadol
FDA accepts additional data submitted in response to May 2007 “approvable” letter.