Allergan To Discuss Tazoral Psoriasis Non-Inferiority Study With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA deems oral tazarotene "not approvable." In addition to a non-inferiority study, Allergan must develop an "acceptable" risk management program and resolve manufacturing problems.
You may also be interested in...
Allergan To Conduct Additional Tazoral Pivotal Trial
Allergan receives a written response from FDA concerning the company's request for dispute resolution over the oral tazarotene NDA, which is "not approvable" at the agency. In addition to the new clinical trial, Allergan will supplement pharmacokinetic and toxicology data.
Allergan To Conduct Additional Tazoral Pivotal Trial
Allergan receives a written response from FDA concerning the company's request for dispute resolution over the oral tazarotene NDA, which is "not approvable" at the agency. In addition to the new clinical trial, Allergan will supplement pharmacokinetic and toxicology data.
Allergan, FDA To Meet On Tazoral NDA Deficiencies By Year-End
The meeting follows a Sept. 24 "not approvable" letter for the psoriasis treatment tazarotene. Allergan says the meeting is needed to provide insight into trial design for a non-inferiority trial.