Biovail Corporation (BVF) Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version To Provide Treatment Option For Those Who Suffer From Moderate To Moderately Severe Pain
10/19/2005 5:10:27 PM
TORONTO--(BUSINESS WIRE)--May 6, 2005--Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an Approval Letter from the United States Food & Drug Administration (FDA) for Tramadol ODT (tramadol hydrochloride), an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride in 50mg dosage format, intended for the treatment of moderate to moderately severe pain in adults.
In March, Biovail filed a Complete Response to address routine matters raised in the Approvable Letter received from the FDA in early January. More specifically, these matters involved the resolution of labeling issues only, including, but not limited to, resolution of final packaging, content and format for the product's blister card and carton.