EDMONTON, June 23 /CNW/ - Isotechnika Pharma Inc. is providing the following information as a follow-up to the news release issued this morning. The U.S. Food and Drug Administration (FDA) has posted additional information on the Office of Federal Register website with regards to the cancellation of the Dermatology and Ophthalmology Drugs Advisory Committee meeting that was scheduled for June 28, 2010 to review partner, Lux Biosciences', New Drug Application (NDA) for voclosporin. As stated on the website at http://www.federalregister.gov/OFRUpload/OFRData/2010-15352_PI.pdf:
"The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22340 and, as needed, may schedule an advisory committee meeting in the future."
"At this time, the FDA has not communicated all the outstanding issues to Lux for the uveitis application," stated Dr. Robert Foster, President and CEO of Isotechnika Pharma. "They await the action letter from the FDA which is expected on or near the PDUFA date of August 3, 2010 for further clarification."
More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.
We seek Safe Harbour.
SOURCE ISOTECHNIKA PHARMA INC.
For further information: For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., 780-487-1600 (247), 780-484-4105 (fax), email@example.com; Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., 780-487-1600 (225), 780-484-4105 (fax), firstname.lastname@example.org