News
Aquestive Therapeutics receives notification from the FDA that it will not be ready to take action by December 23, 2021 for the NDA for Libervant Buccal Film.
Aquestive Therapeutics, Inc. a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced that, regarding the review of the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters, the FDA sent the following notice to the Company.
“Please refer to your NDA 212641 Libervant resubmission dated June 23, 2021. The purpose of this e-mail is to notify you that the Agency is still considering the regulatory issues related to the approvability of Libervant, and will not be ready to take an action by December 23, 2021. No additional information is needed from you at this time. We are currently unable to provide an estimate of the timing of an expected action; however, we will provide any updates we can as they are available.”
Condition: Epilepsy
Type: drug
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