888-451-4321Lenoir, NC February 17, 2017 – Exela Pharma Sciences today announced that it received FDA approval for Ganciclovir Injection in 0.8% sodium chloride solution.
Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV disease in adult transplant recipients at risk for CMV disease. Ganciclovir carries a boxed warning. Please see safety information below and additional important safety information in the full prescribing information by clicking here.
Exela’s Ganciclovir Injection is the first ganciclovir product available in a ready to use formulation. Ready to use sterile formulations, where available, have generally been recommended by the Joint Commission, American Society of Health System Pharmacists (ASHP), and the Institute for Safe Medication Practices.1 Ready to use formulations have been shown to eliminate costs, save time and reduce effort for the institution. Exela’s ganciclovir injection will be available in a ready to use 250ml bag containing 0.8% sodium chloride solution at a pH of 7.5 and is stable for 24 months from manufacturing. Health systems can keep Ganciclovir Injection readily available in the pharmacy, in automated dispensing cabinets or on the floor and use it as needed.
“Exela is pleased to introduce a ready to use formulation of Ganciclovir Injection.” said Dr. Phanesh Koneru, CEO and President, Exela. “Developing injectable products that improve patient and provider experiences is an important goal for Exela. I thank all of our Exela employees that worked tirelessly to make this product a reality, and continue to help create and secure high paying US manufacturing jobs in our North Carolina facilities.”
“Ganciclovir Injection is a ready to use product that was designed with the convenience of the healthcare provider in mind. We are very pleased to offer differentiated value-added product such as Ganciclovir Injection,” said Mark Hartman, Chief Commercial Officer for Exela. “This is consistent with our commitment to serve the institutional practitioners with products that meet their professional and patient needs.” Launch of Ganciclovir Injection to hospitals will begin shortly.
About Ganciclovir Injection – Please see full Prescribing Information
WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, and CARCINOGENICITY
Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir [see Warnings and Precautions].
Impairment of Fertility: Based on animal data, GANCICLOVIR INJECTION may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ]. Fetal Toxicity: Based on animal data, GANCICLOVIR INJECTION has the potential to cause birth defects in humans [see Warnings and Precautions ]. Mutagenesis and Carcinogenesis: Based on animal data, GANCICLOVIR INJECTION has the potential to cause cancer in humans [see Warnings and Precautions ].
Please see additional important safety information in the full prescribing information by clicking here.
About Exela Pharma Sciences
Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing proprietary and generic injectable and sterile ophthalmic products with the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives and meet the needs of the healthcare providers that treat them. Built from a strong Research and Development, Regulatory and Quality foundation, Exela is focused on delivering excellence in Quality, Reliability and Affordability. Established in 2005 by a former Pharmacist, Exela is headquartered in Lenoir, N.C. Please visit www.exelapharma.com to learn more.
- American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health Syst Pharm. 2013;70(18):1619-1630,
- Institute for Safe Medication Practices. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for SAFE Preparation of Sterile Compounds. http://www.ismp.org/tools/guidelines/IVSummit/IVCGuidelines.pdf. Accessed February 26, 2016
For more information, contact Mark Hartman