|GeoPharma Announces Dismissal of Class Action Litigation Relating to Mucotrol (TM) |
Tuesday October 4, 8:31 AM EDT
LARGO, Fla., Oct 04, 2005 /PRNewswire-FirstCall via COMTEX/ -- GeoPharma, Inc. (GORX) announced today that a lawsuit alleging that the Company violated federal securities laws by issuing false or misleading public statements relating to the Company's December 1, 2004 announcement of Mucotrol's(TM) clearance by the FDA was dismissed on September 30, 2005 without prejudice by a judge in the United States District Court for the Southern District of New York. The judge did allow plaintiffs twenty days to attempt to replead their claims.
Mihir Taneja, GeoPharma's CEO commented: "We are extremely pleased by the Court's ruling, which granted our motion to dismiss the Complaint. We are aggressively moving forward with the launch of Mucotrol(TM)."
On November 24, 2004, the Food and Drug Administration (FDA) granted 510-K approval for the marketing of Mucotrol(TM) as a medical device. Mucotrol(TM) concentrated oral gel wafer has a mechanical action indicated for the management and relief of pain by adhering to the mucosal surface of the mouth and soothing oral lesions of various origins including oral mucositis/stomatitis, which may be caused by chemotherapy or radiotherapy, irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or diseases.