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Amphastar: FDA Approves Succinylcholine Chloride Injection Multiple-Dose Vial

Amphastar Pharmaceuticals Inc. (AMPH) announced Tuesday that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application or ANDA for Succinylcholine Chloride Injection Multiple-Dose Vial.

In pre-market activity on Nasdaq, shares were gaining around 9.6 percent to trade at $22.

The FDA determined Amphastar's Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial 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, Inc.

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.

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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