Gerresheimer Announces Successful FDA Inspection at Peachtree City Site
The FDA inspection took place from November 17, 2022 to December 12, 2022 at the Gerresheimer facility in Peachtree City. During this time, production at the facility was inspected by drug and device Consumer Safety Officers, who evaluated the management system and production process for disposable cassettes, from incoming raw materials to finished products.
This inspection was a key step for the approval of the third generation GENOSYL Delivery System (DS). The approval presents an important new development in the clinical use of inhaled nitric oxide, and the pent-up demand for this third generation innovation demonstrates its increasing value to the acute care community.
GENOSYL Delivery System (DS) for inhaled nitric oxide was approved by the US FDA in December 2019 and was the first tankless delivery system for inhaled nitric oxide. Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.
Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow. The recently approved third generation GENOSYL DS also includes an innovative dual-cassette design and secondary adaptive sensor technology to further optimize patient care.
GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Important Safety Information
- GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
- Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
- Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
- In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- The most common adverse reaction is hypotension.
- Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
- GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.
VERO Biotech Inc. is a privately held company headquartered in Atlanta, Georgia focused on saving lives, alleviating suffering, and improving health economics in the neonatal intensive care and the acute care hospital communities.
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people’s health and well-being. For more information, visit www.gerresheimer.com.
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