OTC Misfire Salvaged As Rx Prospect: Barrier Touts Antifungal Zimycan Trial
This article was originally published in The Tan Sheet
Executive Summary
Barrier Therapeutics plans to parlay Johnson & Johnson's failed over-the-counter diaper cream Zimycan into the first prescription treatment for diaper rash complicated by Candida yeast infection
You may also be interested in...
Zimycan NDA
Barrier Therapeutics expects a first-action letter from FDA relating to approval of its prescription Zimycan ointment for diaper dermatitis complicated by candidiasis during the first half of 2005, and is gearing up for potential launch in the second half, according to Chief Commercial Officer Al Altomari. Barrier acquired rights for the product in a 2002 licensing agreement with J&J, following a failed attempt to gain OTC clearance (1"The Tan Sheet" Aug. 16, 2004, p. 9). Barrier recently submitted results of a Phase III trial showing significant efficacy superiority versus vehicle in an amendment to its NDA...
Zimycan NDA
Barrier Therapeutics expects a first-action letter from FDA relating to approval of its prescription Zimycan ointment for diaper dermatitis complicated by candidiasis during the first half of 2005, and is gearing up for potential launch in the second half, according to Chief Commercial Officer Al Altomari. Barrier acquired rights for the product in a 2002 licensing agreement with J&J, following a failed attempt to gain OTC clearance (1"The Tan Sheet" Aug. 16, 2004, p. 9). Barrier recently submitted results of a Phase III trial showing significant efficacy superiority versus vehicle in an amendment to its NDA...
Zimycan NDA
Barrier Therapeutics expects a first-action letter from FDA relating to approval of its prescription Zimycan ointment for diaper dermatitis complicated by candidiasis during the first half of 2005, and is gearing up for potential launch in the second half, according to Chief Commercial Officer Al Altomari. Barrier acquired rights for the product in a 2002 licensing agreement with J&J, following a failed attempt to gain OTC clearance (1"The Tan Sheet" Aug. 16, 2004, p. 9). Barrier recently submitted results of a Phase III trial showing significant efficacy superiority versus vehicle in an amendment to its NDA...