Seasonale Lo filing by June 30
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)...
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