FORT COLLINS, Colo., Nov. 3 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. announced today that the company received approval from the U.S. Food and Drug Administration (FDA) for an additional package size, a 5 gram tube of lidocaine/prilocaine cream, 2.5%/2.5% for hospital use.
Atrix's product is the AB-rated generic to EMLA(R) Cream (lidocaine 2.5 percent and prilocaine 2.5 percent), which is marketed by AstraZeneca Pharmaceuticals LP. EMLA is indicated for use as a topical local anesthetic. Hospital sales of EMLA were more than $6 million for the year ended December 2003. Sandoz Inc., a Novartis company, will market the lidocaine/prilocaine 5 gram product.
In August of 2003, Atrix received FDA approval for the ANDA for lidocaine/prilocaine, 2.5%/2.5%, 30 gram tube.
"We are very pleased with this approval," said Michael R. Duncan, Atrix's vice president and general manager. "This allows us to expand our market potential for this product into hospital settings."
About Atrix Laboratories:
Atrix Laboratories, Inc. is an emerging specialty pharmaceutical company focused on advanced drug delivery. With five unique patented technologies, Atrix is developing a diverse portfolio of proprietary products, including oncology, pain management, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the patent life of existing products. Additional information is available on the Atrix Laboratories, Inc. website at http://www.atrixlabs.com/.
This press release contains statements that qualify as "forward-looking statements" under the Private Securities Litigation Reform Act of 1995, including statements related to the company's expectations that Sandoz will be able to successfully market these products or any of the company's other products, statements related to the company's accomplishments, statements related to the company's expectations that any of its approved products will be successfully marketed and statements regarding the company's confidence that the shareholders will benefit from the company's continued efforts to build revenue from the sales of generic products. The company is subject to certain risk factors that may cause actual results to differ materially from anticipated results. Those risks include, but are not limited to, risks associated with product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development and competition from other products and treatments. For additional information about risk factors, please see the reports filed by the company with the SEC, including the company's Annual Report on Form 10-K for the year ended December 31, 2003 and the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2004. All forward-looking statements in this press release are made as of the date hereof, based on information available to the company as of the date hereof, and the company assumes no obligation to update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized. EMLA(R) is a registered trademark of AstraZeneca Pharmaceuticals.
Atrix Laboratories, Inc.