Velcera Announces Positive FDA Meeting on VEL504 Product
Published: Jun 02, 2008
YARDLEY, PA--(Marketwire - June 02, 2008) - Velcera, Inc. (OTCBB: VLCR), a specialty pharmaceutical company focused on pet health, announced today positive results from its presubmission conference with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) concerning Velcera's novel canine pain management product. The meeting confirmed the current Promist™ product formulation is approvable by CVM in accordance with the customary regulations pending completion of the development program as previously planned and agreed upon with CVM. No changes or additions to the plan of development or revisions to current protocols are necessary. This novel product out-licensed in 2007 and now under development by Velcera is positioned to move forward toward regulatory approval.