Rösch AG Medizintechnik
Rösch AG Medizintechnik english

FDA approval of INJEX systems Ad-hoc-announcement transmitted by DGAP. The issuer is solely responsible for the content of this announcement. ——————————————————————————– FDA approval of INJEX systems Rösch AG Medizintechnik (SIN 529 140) announces that it has received the approval (510 K) of the U.S. Food and Drug Administration (FDA) for its needle free injection systems. This approval allows Rösch AG to market its reusable injection system INJEX and its single used injection system ROJEX for needle free, subcutaneous drug application in the U.S. market. ‘Of course we are very proud of having received the FDA approval for our INJEX and ROJEX system’, said Prof. Weidler, CEO of Rösch AG. ‘Now there is no additional regulatory clearance needed to start the marketing of our INJEX system in the United States.’ In consequence of this clearance INJEX will now also be launched in the USA in the indication of growth hormone application via a cooperation partner, who already sells INJEX in this indication in Europe. ‘The acceptance of our needle free INJEX technology through the FDA will make it easier to get regulatory approval also in other countries who are traditionally closely related to the FDA procedure like the Middle East, India, Asia, Australia and South Africa. This clearance will in addition suport FDA approvals of Rösch’s new developments (to be filed) like INJEX OneWay and INJEX All-in- one’, Prof. Weidler stated. Further information: Rösch AG Medizintechnik, Buckower Damm 114, 12349 Berlin Tel: 030-667915-0, Fax: 030-667915-66, mail: vorstand@roesch-ag.de end of ad-hoc-announcement (c)DGAP 30.09.2002 ——————————————————————————– WKN: 529140; ISIN: DE0005291405; Index: Listed: Neuer Markt in Frankfurt; Freiverkehr in Berlin, Bremen, Düsseldorf, Hamburg, Hannover und Stuttgart 301317 Sep 02