Amphastar Pharmaceuticals Receives FDA Approval for Calcium Chloride Injection

RANCHO CUCAMONGA, Calif., May 14, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. ( AMPH) announced that the U.S. Food and Drug Administration (“FDA”) granted approval of the company’s abbreviated new drug application (“ANDA”) for Calcium Chloride injection 10% in the 10 mL Luer-Jet ®Prefilled Syringe System.

For the past 40 years, the company has sold and marketed the product under the “grandfather” exception (now termed “unapproved”) to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the company’s Calcium Chloride injection for the year ended December 31, 2017 were $13.5 million.