Vials containing injection.

Amphastar obtains FDA OK for morphine sulfate injection

Amphastar has sold and marketed under the "grandfather" exemption to the FDA's "Prescription Drug Wrap-Up" program.
Sandra Levy
Senior Editor
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Amphastar has received the Food and Drug Administration’s blessing for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet Prefilled Syringe System.

The medication is indicated for the management of pain severe enough to require use of an opioid analgesic by patient-controlled analgesia, only for use with a compatible Alaris infusion device, and for which alternative treatments are inadequate.

For the past 30 years, the company has sold and marketed the product under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the company’s Morphine injection for the year ended Dec. 31, 2020, were $2.3 million.

“The FDA’s approval of Morphine injection shows the company’s continued commitment and ability to manufacture high quality injection products,” said Amphastar CEO and president Jack Zhang.