Business Services Industry
DENTSPLY International Inc. Reports Completed MRP Filing for Oraqix
Business Wire, April 28, 2004
Business Editors/Health/Medical Writers
YORK, Pa.--(BUSINESS WIRE)--April 28, 2004
DENTSPLY International Inc. (NASDAQ:XRAY) today announced that on April 1, 2004 it completed its filing for a Mutual Recognition Procedure (MRP) for Oraqix(TM) in 15 European Union/European Economic Area countries. These include the United Kingdom, France, Germany, Luxembourg, Denmark, Italy, the Netherlands, Finland, Norway, Ireland, Belgium, Spain, Portugal, Iceland and Austria. The MRP allows a filing throughout the EU based on the approval of Marketing Authorization in an EU member country. The filing was validated in all countries and the MRP is now in process.
Oraqix is a revolutionary non-injectable anesthetic for periodontal applications. Oraqix is delivered to the treatment site without the use of a needle and anesthetizes the site within 30 seconds for a period of approximately 20 minutes.
DENTSPLY and its marketing subsidiaries submitted its filing based on the approved marketing authorization received for Oraqix in Sweden on March 7, 2003. Subject to approvals under the MRP, DENTSPLY will work with the individual country regulatory agencies to finalize packaging and patient information leaflets. DENTSPLY expects Oraqix to be marketed in Sweden in the last quarter of 2004 and in the rest of the filed European countries in early 2005.
DENTSPLY designs, develops, manufactures and markets a broad range of products for the dental market. The Company believes that it is the world's leading manufacturer and distributor of dental prosthetics, precious metal dental alloys, dental ceramics, endodontic instruments and materials, prophylaxis paste, dental sealants, ultrasonic scalers, and crown and bridge materials; the leading United States manufacturer and distributor of dental handpieces, dental x-ray film holders, film mounts and bone substitute/grafting materials; and a leading worldwide manufacturer or distributor of dental injectible anesthetics, impression materials, orthodontic appliances, dental cutting instruments and dental implants. The Company distributes its dental products in over 120 countries under some of the most well established brand names in the industry.
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