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NASDAQ: AMPH

Amphastar Pharmaceuticals on Tuesday revealed that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Glucagon for Injection Emergency Kit, 1 mg.

Glucagon is used for the treatment of severe hypoglycemia and is also used as a diagnostic aid.

Amphastar said its synthetic peptide product was determined by the FDA to be therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar.

“This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon,” commented Dr Jack Zhang, Amphastar’s CEO and President.

According to IQVIA data, US sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar were approximately $144 million, with the overall US sales of brand products containing glucagon for injection, 1 mg, being roughly $306 million for the 12 months ended September 30.

Amphastar plans to launch its kit within two months.

The company’s stock price has risen by over 26% premarket, trading at $23.98 following Monday’s close ta $19.02.

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