Amphastar Pharmaceuticals Receives FDA Approval for Calcium Chloride Injection
Amphastar Pharmaceuticals, Inc. (AMPH)
Last amphastar pharmaceuticals, inc. earnings: 3/12 04:05 pm
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Source: GlobeNewswire
RANCHO CUCAMONGA, Calif., May 14, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: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. Amphastar's CEO, Dr. Jack Zhang, stated: "We are pleased about the FDA’s approval of our Calcium Chloride injection which continues to demonstrate our commitment to work with the Agency to alleviate drug shortages." The company continues to market four unapproved products, and has two ANDAs and one NDA pending approval for these products. For the year ended December 31, 2
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