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The “train war” between Daewoong Pharmaceutical and Medytox over the source of the botulinum toxin strains and the unauthorized use of them has entered a new phase.
Daewoong Pharmaceutical announced that it would file a petition with the US Food and Drug Administration (FDA) for cancellation of approval of Medytox’s botulinum toxin drug ‘Innotox’.
On the 29th, Daewoong Pharmaceutical announced that it would submit a petition to the FDA to request an investigation into Innotox’s safety data.
The botulinum toxin formulation of Medytox ‘Innotox’ was canceled from the Ministry of Food and Drug Safety on the 18th. This is because, as a result of the investigation by the prosecution, the circumstances of manipulation of the data of the stability tests in the product approval process and approval of changes for Innotox.
Daewoong Pharmaceutical said: “Innotox was the only bond that could claim jurisdiction in the United States in relation to the case (ITC litigation) because Allergan submitted its Medytox sales rights. Therefore, the cancellation of Innotox’s permit is a serious event that shakes the foundations of the ITC litigation. ”
He added: “As part of the ITC administrative investigation, we have no choice but to issue a formal issue with Medytox’s revocation of Innotox permits to demonstrate the unfairness of ITC’s decision, and we intend to file a petition requesting a closure investigation with the FDA. ”
In the US International Trade Commission (ITC) lawsuit in which Daewoong Pharmaceutical and Medytox fought fierce battles last year, Daewoong Pharmaceutical received an order to ban exports of botulinum toxin ‘Nabota (export name) ‘for 21 months.
Allergan, which introduced Innotox from Medytox, is currently conducting a phase 3 clinical trial in the US for local commercialization. Daewoong Pharmaceutical insisted that the stability data submitted by Medytox to the FDA for approval of Innotox products would have been manufactured as in Korea.
Daewoong Pharmaceutical said: “The FDA imposes very strict penalties against data integrity violations, such as data tampering. In the case of a serious infringement, the license can be canceled or an import ban can be imposed. Therefore, the FDA will seriously handle the national approval of Innotox. ”
Meanwhile, Daewoong Pharmaceutical is preparing to appeal the ITC’s final decision. The president of the United States must approve or veto the final decision of the ITC committee within 60 days.
On that day, a Daewoong Pharmaceutical official said: “We are closely watching whether the President of the United States approves the final judgment of the ITC. If the ruling is approved, we plan to proceed with the appeal immediately. ”
