OXFORD, England, June 24 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (Nasdaq: OGSI; London: OGS) today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) on its new drug application (NDA) for Vevesca (OGT 918). In the letter, the FDA stated that, in its opinion, the product is not approvable, as OGS has not provided sufficient support for the safety and efficacy of Vevesca (OGT 918). Therefore, the FDA has stated that the application may only be approved if a number of issues are addressed and further clinical studies are conducted.
In addition, the letter stated that within 10 days from its receipt, OGS must either amend its application, notify the FDA of its intent to file an amendment, withdraw the application or request an opportunity for an informal meeting on whether there are grounds for denying approval of the application. OGS will formally request a meeting with FDA representatives as soon as possible to review this letter and to find the best way forward. Following this meeting, OGS will then notify the FDA which alternative it will pursue.
OGS has also filed a Marketing Approval Application for Vevesca (OGT 918) with the European regulatory authority, the EMEA. This process is at an advanced stage and a decision from the EMEA is anticipated during the third quarter 2002. |
