Allergan Tazoral regulatory update
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Allergan plans to conduct an FDA-requested clinical study of its oral tazarotene formulation Tazoral, as well as provide additional pharmacology and toxicology data, the firm says June 1 after receiving FDA's written response to a dispute resolution request for a September 2004 "not approvable" letter. The agency "outlined multiple potential options for improving oral tazarotene's risk-benefit profile," Allergan stated. "Based on…F DA's recommendations, Allergan plans to submit a development plan…a nd will provide details once an agreement has been reached." A July 2004 advisory committee deemed the company's risk management plan for the retinoid to be inadequate (1Pharmaceutical Approvals Monthly October 2004, In Brief)...
You may also be interested in...
Allergan Tazoral "not approvable"
Allergan will continue seeking a psoriasis indication for its oral tazarotene product Tazoral, the firm says following FDA's Sept. 24 "not approvable" letter. Among the "non-approvability issues" are the needs for a non-inferiority trial in severe psoriasis, an "acceptable" risk management plan and manufacturing deficiencies. Allergan "will work with the FDA to clarify" the request for a non-inferiority trial. The firm says it is "in the process of developing an appropriate risk mangement plan." The manufacturing issue "is either resolved or will be resolved shortly to the FDA's satisfaction," Allergan says. FDA's Dermatologic & Ophthalmic Drugs/Drug Safety & Risk Management advisory committees said that the Tazoral risk management plan was inadequate during a July 12 joint meeting...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.