Because the NDA remains approved, the relaunch needs stability, fill and validation work, not new clinical trials.
NitroMist (NDA 021780) was approved in 2006, marketed in the U.S. from 2011 and voluntarily discontinued in 2022 by a prior owner for reasons unrelated to safety or efficacy. Under prior ownership it reached peak sales of about US$40 million a year, under the direction of Humberto Borque, who now leads the relaunch for Vicapsys.
An alcohol-free, propellant-driven metered dose designed to withstand freeze-thaw and heat cycling in field, EMS, military and rural storage, where conventional nitrates fail. It returns as a deliberately limited-distribution product on a narrow formulary, through Stateline's accounts and the federal and tribal channel.
- Product
- Nitroglycerin lingual aerosol
- Application
- NDA 021780, approved 2006
- Peak sales under prior ownership
- About US$40 million a year
- Status
- Purchase agreement signed; relaunch under way