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Amphastar gets FDA approval for succinylcholine chloride injection

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RANCHO CUCAMONGA, Calif. — Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application  for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial. Amphastar’s newly approved drug product was determined by the FDA to be therapeutically equivalent to Quelicin (succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial) distributed in the United States by Pfizer. Succinylcholine chloride injection is for intramuscular and intravenous use. It is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Amphastar’s CEO and president, Dr. Jack Zhang, commented: “We would like to thank the FDA review team for working diligently and approving this application in its first review cycle. This approval highlights the strengths of our quality systems and regulatory capabilities in pipeline development.”

According to IQVIA, U.S market annual sales for the 12 months ended March 31, 2020 for succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial was approximately $75 million.

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