Regarding Allergan and Medytox's filing with the U.S. International Trade Commission (ITC) in January to block sales of Nabota (DWP-450, Jeuveau in the U.S.), Daewoong Pharmaceutical Co. announced on March 4 that they should take responsibility for groundless allegations.
Daewoong said, "The ITC lawsuit is part of the typical market defense strategy when competing products are released in the U.S. The charges raised by the plaintiffs in this lawsuit are no different from the claims made in the previous civil lawsuit."
It added that the application was received in a lawsuit that decides whether or not intellectual property rights are infringed in accordance with the U.S. Customs Law and it is a routine procedure to determine the opinions presented by both sides.
According to related industries, the Food and Drug Administration (FDA) rejected the Medytox-led petition made on Feb. 1 (local time) with the same content as ITC complaint.
The FDA said in an answer that it found no fraudulent activity that could be suspected of being false in the official statement of the Daewong Pharmaceutical.
"The lawsuit is nothing more than a groundless fiction as shown in the FDA's answer to the petition," a Daewoong official said. "We are confident that it will not affect the Navota exports to the U.S. at all."
Meanwhile, Daewong Pharmaceutical said Nabota will be released in the U.S. this spring as scheduled, following the FDA approval for the sale.