Owned products

NitroMist^®: an FDA-approved product coming back to market.

A nitroglycerin lingual aerosol for angina, approved in 2006 and off the market since 2022 for reasons unrelated to safety or efficacy. Vicapsys signed a definitive purchase agreement in September 2026; closing follows FDA acknowledgment of the transfer of the NDA.

2006

FDA approval (NDA 021780); marketed in the U.S. from 2011

400 mcg

nitroglycerin per metered spray; 90-spray and 230-spray bottles

$40M

approximate peak annual sales under prior ownership, per management

new clinical trials required: the NDA remains approved

The product

This page describes a corporate asset. It is not prescribing information, which will be made available when the product is relaunched.

Name: NitroMist^® (nitroglycerin) lingual aerosol
Application: NDA 021780, approved by the FDA in 2006
Dose and packaging: 400 mcg per metered spray; 90-spray and 230-spray bottles
Indication: Acute relief of an attack, or acute prophylaxis, of angina pectoris due to coronary artery disease
History: Marketed in the U.S. from January 2011; voluntarily discontinued at the end of 2022 by a prior owner for reasons unrelated to safety or efficacy¹⁰
Status: Definitive purchase agreement signed September 2026; closing on FDA acknowledgment of the NDA transfer. Not currently available.

Why it is different. NitroMist is an alcohol-free, propellant-driven metered dose. It is designed to withstand freeze-thaw and heat cycling in field, EMS, military and rural storage, where conventional nitrates fail. Because the NDA remains approved, the relaunch needs stability, fill and validation work, not new clinical trials.

The relaunch

Led by Humberto Borque, who directed NitroMist under prior ownership when it reached peak sales of about US$40 million a year.

Narrow formulary, limited distribution

NitroMist returns deliberately as a limited-distribution product on a narrow formulary, with preferred-formulary placement sought at the pharmacy benefit managers.

Channels Vicapsys already holds

Stateline's commercial accounts in Puerto Rico and on the mainland, and the federal and tribal channel through the company's 8(a) teaming partner, where Vicapsys would be the only FDA-approved source.

What has to happen first

FDA acknowledgment of the NDA transfer, then the stability, fill and validation work that any relaunch of an approved product requires. Supply at relaunch comes from a contract manufacturing partner.

Beyond angina

A second indication is planned. Any development there will be described in the company's public disclosures.

Pedigree

NitroMist was brought to market by Joe Krivulka, founder of Reliant Pharmaceuticals, the company GlaxoSmithKline bought for US$1.65 billion.¹¹ He spent his career taking the drugs Big Pharma forgot and making them famous. NitroMist was one of them.

Vicapsys follows the same approach: acquire FDA-approved brands that larger companies have set aside and relaunch them through channels the company controls, with no new clinical risk.

Sources: ¹⁰ NovaDel Pharma Inc., Form 10-K for 2010; FDA NDA 021780 · ¹¹ GlaxoSmithKline (2007). Peak sales per management. The full list is on the platform page.

NitroMist®: an FDA-approved product coming back to market.