Barrier Therapeutics announced that the FDA has issued a "not approvable" letter for its new drug application for Zimycan, a treatment for diaper dermatitis complicated by candidiasis. Princeton, New Jersey-based Barreir said the rejection was based on a single deficiency: insufficient information to characterize the systemic exposure to miconazole in infants, which is part of the treatment's safety evaluation. But Barrier says that it isn't giving up on the therapy.
"We are disappointed and surprised by the FDA's decision; however, Barrier remains dedicated to bringing this product to the market," said Geert Cauwenbergh, PhD, chairman and CEO of Barrier Therapeutics. "The company stands fully behind the safety profile of this 0.25% concentration of miconazole. Barrier will continue discussions with the Agency and is looking at all available options. We believe that one option is to conduct a second percutaneous absorption study using the current product."
- read this press release for more on the decision