Nuvo/Galderma Face More Manufacturing Woes Over Topical Anesthetic
This article was originally published in The Pink Sheet Daily
Executive Summary
Galderma pulled Pliaglis from the market in 2008 over manufacturing issues, which the specialty pharma thought were resolved when it submitted an sNDA last fall. Regulators, however, still have questions surrounding the daub on, peel off product’s manufacture, which has now been transferred from a third-party to Galderma.