The new spray, called NitroMist - Nitroglycerin Lingual Aerosol - has been approved by the Food and Drug Administration (FDA) for acute relief of an attack or acute prophylaxis of angina pectoris.
The generics pharmaceutical company, which provides alternative methods of delivery of drugs already on the market, claims its oral spray delivery technology provides faster absorption and onset drug action than the currently used tablet form dosage.
NitroMist is the company's first product utilising its proprietary oral spray technology to be approved.
Angina pectoris is a common symptom, typically chest pain, among patients with coronary artery disease which results in discomfort or pressure due to transient myocardial ischemia. It is typically precipitated by physical effort and relieved by rest or sublingual nitroglycerin tablets, which is the main treatment available.
Nitroglycerin pills popped under the tongue provide an immediate boost of nitric oxide, which relaxes the vessels to the heart and lets more blood flow come in.
Approximately 6.3m Americans are estimated to experience angina and an estimated 350,000 new cases of angina occur every year, according to the American Heart Association.
The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc.
"With this approval, we will now focus our resources on the rapid advancement of our pipeline of compounds that promise to provide faster onset of action and more patient-friendly dosing," said Jan Egberts, president and CEO of NovaDel.
"We are particularly excited about the potential of Sumatriptan oral spray and Zolpidem oral spray, which respectively target patients suffering from migraines and insomnia."