“We are surprised to receive this notification from the FDA. We accepted all of the Agency’s label edits for Libervant last week and, as the Agency stated in its notice today, there is no additional information needed from the Company at this time. Following the labeling discussions, we believe the package we submitted satisfies all of CDER’s requests,” said Keith Kendall, Chief Executive Officer of Aquestive.
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What could be the reason for the delay and will it rather take days or weeks to solve this problem?
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