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Zars, Inc. Announces FDA Actions On S-Caine Products



10/19/2005 5:10:10 PM

SALT LAKE CITY--(BUSINESS WIRE)--Feb. 26, 2004--ZARS Inc., a privately held Salt Lake City-based pharmaceutical company that develops and markets products for pain, anxiety disorders and nausea, announced today that the Food and Drug Administration has issued a letter of approvability for the company's first product, the S-Caine Patch®. Once this New Drug Application (NDA) is approved, this product will be used to numb quickly the skin of babies, children and adults before painful procedures, such as IV catheter placement, and other minor dermatological interventions. ZARS' partner with this product is Ferndale Laboratories, a Michigan-based dermatological products company. In November of last year ZARS submitted a second NDA for the S-Caine Peel®, a cream that topically numbs larger areas of the skin before painful cosmetic laser procedures, such as facial resurfacing and removal of unwanted hair, spider veins and tattoos. The FDA accepted the S-Caine Peel® NDA submission for filing, and a decision by the agency is expected by mid-September. Johnson & Johnson is ZARS' partner with this product.

ZARS currently has five open INDs and two pending NDAs.

Since its founding as a spinout from the University of Utah in 1997 by Jie Zhang, Ph.D, Michael Ashburn, M.D., Larry Rigby and Theodore Stanley, M.D., ZARS has been developing proprietary skin patches that deliver drugs into and through the skin, using patented CHADD (controlled heat assisted drug delivery) technologies.

Contact:

ZARS Inc., Salt Lake City Larry Rigby, 801-350-0202 Mobile: 801-556-1880 ldr@zars.com www.zars.com

Source: ZARS Inc.


Read at BioSpace.com

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