For severe liver disease. NDA 210660, held by Exela Pharma. Cysteine Hydrochloride.
As of Nov 13, 2026, NDA 210660 (Elcys), held by Exela Pharma, was first approved by FDA on Apr 16, 2019, with 1 approved supplement and 0 published complete response letters.
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. ELCYS is a sulfur-containing amino acid indicated 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2019 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Elcys500MG/10ML (50MG/ML) · solution;intravenous | Cysteine Hydrochloride | RxReference drug |
| Elcys2500MG/50ML (50MG/ML) · solution;intravenous | Cysteine Hydrochloride | RxReference drug |
| Dec 4, 2023 | Supplement 5Manufacturing | Approved | |
| Apr 16, 2019 | Original applicationNew formulation or manufacturer · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
