This designation indicates that the appropriate information has been provided for the review of the new drug application. The company believes that this review will be completed within approximately six months from the date of the submission of the response, which occurred in August 2005.
The FDA has also approved the company’s recommendation for the use of Vusion as the proposed brand name for the product.
The not approvable letter dated May 24, 2005 said that there was insufficient information in the new drug application to characterize the systemic exposure to the active ingredient miconazole in infants. The response filed by the company contains additional information to address this deficiency.
“The conversations that we held with the FDA during the summer were very constructive,” stated Dr Geert Cauwenbergh, chairman and CEO of Barrier Therapeutics. “We are happy to have Vusion back under review by the agency, taking us another step closer to bringing this product to the market.”