Amphastar Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved its generic calcium chloride injection.
The Rancho Cucamonga, Calif.-based specialty pharmaceutical company said the U.S. regulator approved the abbreviated new drug application for calcium chloride injection 10% in the 10-milliliter Luer-Jet Prefilled Syringe System.
Amphastar said it has been selling the product for the past 40 years under the grandfather exception to the FDA's Prescription Drug Wrap-Up program, and net revenues were $13.5 million for the year ended Dec. 31, 2017.
