Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial

RANCHO CUCAMONGA, Calif., June 09, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) (“Amphastar”), today announces that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) 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, 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.

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.

Pipeline Information

The Company currently has five ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.7 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and nine generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended March 31, 2020. The Company is developing multiple proprietary pipeline products for injectable and intranasal dosage forms, including a new drug application for intranasal naloxone. 

Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMF, on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products.  Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.  More information and resources are available at www.amphastar.com.