Enhanced Formulation of Pliaglis Receives FDA Approval
The FDA has approved the enhanced formulation of lidocaine and tetracaine following its statutory 6-month review process and in line with the target action date under the Prescription Drug User Fee Act.
The FDA has approved the enhanced formulation of lidocaine and tetracaine (Pliaglis, Crescita Therapeutics Inc.) following its statutory 6-month review process and in line with the target action date under the Prescription Drug User Fee Act.
A lidocaine and tetracaine (7%/7%) formulation, Pliaglis is a prescription topical local anesthetic cream approved to provide safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures, such as dermal filler injections, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.
While the United States patent covering the original formulation of lidocaine expired on September 28, 2019, the patent covering the enhanced formulation with extended protection to 2031 is in the process of being added to the Orange Book.
"We are delighted with the FDA's approval of the Enhanced Formulation of Pliaglis," said Serge Verreault, president and CEO of Crescita. "With an improved formulation and extended patent protection, we are very optimistic about extending the commercial life of Pliaglis for many years to come."
Reference
- U.S. Food and Drug Administration Approves Enhanced Formulation of Pliaglis® [press release]. PR Newswire website. Published November 5, 2019.https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-enhanced-formulation-of-pliaglis-300952361.html. Accessed November 6, 2019.
