Lenoir, NC May 31, 2019 – Exela Pharma Sciences is pleased to announce the approval and immediate launch of ELCYS™ (cysteine hydrochloride injection), USP, the only FDA Approved cysteine hydrochloride injection on the market in the United States. ELCYS™ was approved under priority review as a New Drug Application (NDA). It is not an Abbreviated New Drug Application (ANDA) product. The NDA is the result of significant research and development aimed at lowering the Aluminum content in the drug product. ELCYS™ is labeled to contain no more than 120 parts per billion (mcg/L) of Aluminum.
ELCYS™ is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ASPEN (American Society for Parenteral and Enteral Nutrition) guidelines range from between 20-40mg per gram of amino acid.
Risk of Aluminum Toxicity
Aluminum is a known contaminant of parenteral nutrition (PN) solution components. Premature neonates requiring high doses of calcium and phosphate to mineralize their bones, children with impaired renal function, and children on PN therapy for prolonged duration are at the highest risk. The Aluminum risk is not limited to neonates and children. Even with ELCYS™ which contains no more than 120 ppb of Aluminum, the Aluminum risk remains. Please see Section 5 (Warnings and Precautions, and specifically, Section 5.7, Aluminum Toxicity), Section 6 (Adverse Events), and Section 8 (Use in Specific Populations, and specifically Section 8.4, Pediatric Use) in the approved Prescribing Information as shown in DailyMed.
“We at Exela sincerely hope that practitioners and health systems recognize and appreciate the development efforts that were needed to bring to market the first FDA approved Cysteine Injection NDA product with no more than 120 ppb of Aluminum,” said Dr. Phanesh Koneru, CEO and President, Exela. “We look forward to clinician support of ELCYS™ which helps us to continue to develop differentiated and valued products.”
“Exela is pleased to launch another critical product from our North Carolina facilities,” commented Mark Hartman, Chief Commercial Officer. “The development and manufacturing of ELCYS™ has been the result of the strong team dedication of our employees and their desire to develop and market products that make a difference in patient care and outcomes.”
ELCYS™ is available direct from Exela immediately and will be in wholesalers in early June.
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.
For more information, contact Mark Hartman at mhartman@exela.us