Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
“The FDA’s acceptance for review of this application for nitroglycerin powder for sublingual use represents a key milestone in advancing treatment options and benefits to individuals with this critical cardiovascular condition,” said Quang Pham, CEO.
“This novel presentation represents the first product innovation in this category in nearly 20 years.”
The product was developed by Pohl-Boskamp, a fully-integrated German pharmaceutical company with a 175-year operating history. Espero has an exclusive licensing and distribution agreement with Pohl-Boskamp in the US market and is supporting the submission of this NDA to the FDA. A proven innovator in the nitroglycerin category, Pohl-Boskamp is also the owner of the NDA for Nitrolingual Pumpspray approved by FDA in 1997.
The FDA has set an action date of June 10, 2016 to complete its review, as per the Prescription Drug User Fee Act (PDUFA).