Wellbutrin XL Generic From IntelGenx/Cary Pharma Delayed By Manufacturing, Food Effect Concerns
This article was originally published in The Pink Sheet Daily
Executive Summary
"Complete response" letter from FDA should be addressed by the end of the year, firms state.
You may also be interested in...
Wellbutrin XL Generic Needs Longer Study To Assess Switch Issues, Biovail Asserts
Bioequivalencey isn't the issue, Biovail says in response to proposed Teva study, arguing a much larger and differently designed trial should be conducted to investigate clinical differences between the generic and brand.
Teva’s Generic Bupropion XL Meets Bioequivalence To Wellbutrin XL, FDA Finds
Reported loss of antidepressant effect likely owed to natural disease progression, agency says.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.