SAN DIEGO, April 10 (UPI) -- Novalar said Tuesday it filed a new drug application with the U.S. Food and Drug Administration for NV-101, a dental anesthetic reversal agent.
The company said pivotal studies showed NV-101 returned sensation and function in patients receiving local dental anesthesia in less than half the time it usually takes.
"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," said Donna Janson, Novalar's president and chief executive officer.
"We will also continue to put in place the necessary marketing and commercialization infrastructure to ensure a successful product launch," Janson added.
Novalar said no serious adverse events were reported with NV-101 in two phase 3 trials.
