Amphastar Pharma Gets Approval For Its Morphine Sulfate Injection- Quick Facts

(RTTNews) - The Food and Drug Administration approved the Abbreviated New Drug Application (ANDA) submitted by Amphastar Pharmaceuticals Inc. (AMPH) for its Morphine Sulfate injection, the company said in a release.

The approved 1mg/mL morphine Sulfate injection in the 30mL Pump-Jet Prefilled Syringe System is indicated for the management of pain severe enough to require use of an opioid analgesic by Patient-Controlled Analgesia (PCA), only for use with a compatible Alaris infusion device, and for which alternative treatments are inadequate.

The company has been selling the product for the past 30 years under the "grandfather" exception to the FDA's "Prescription Drug Wrap-Up" program.

Amphastar's morphine injection had brought in sales of $2.3 million for the year ended December 31, 2020.

"The FDA's approval of Morphine injection shows the Company's continued commitment and ability to manufacture high quality injection products," Amphastar's CEO and President, Dr. Jack Zhang, commented.