Novalar Pharmaceuticals, Inc.’s NV-101 is a local dental anesthetic reversal agent that has shown efficacy in pivotal studies.
Novalar has already applied for NV-101’s marketing approval to the USFDA.
According to Donna Janson, President and Chief Executive Officer of Novalar:
"The submission of the NV-101 NDA is a key regulatory milestone for Novalar and we will maintain a close interface with the FDA throughout the NDA review process.
We will also continue to put in place the necessary marketing and commercialization infrastructure to ensure a successful product launch.
In addition, we have intensified our business development efforts to identify and evaluate promising in-licensing opportunities to add to our product pipeline."
Phase 3 studies of NV-101 demonstrated its safety and efficacy.
Find more details from the full report.
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