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08/22/2022

Amphastar obtains FDA blessing for epinephrine pre-filled syringes

Epinephrine injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Sandra Levy
Senior Editor
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The Food and Drug Administration has granted Amphastar approval for epinephrine injection, 1 mg/10 ml (0.1 mg/ml) single dose pre-filled syringe.

Epinephrine injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

[Read more: FDA gives Amphastar tentative OK for vasopressin injection]

For the past 30 years, the company has sold and marketed epinephrine injection under the grandfather exception to the FDAs Prescription Drug Wrap-Up program.

Net revenues for the companys epinephrine injection for the year ending Dec. 31, 2021 were $27.8 million. Epinephrine injection is the final product that Amphastar markets under the grandfather exception.

[Read more: Amphastar obtains FDA OK for morphine sulfate injection]

When we went public eight years ago, we had six products which were marketed under the grandfather exception, said Jack Zhang, Amphastars CEO and president. The approval of epinephrine pre-filled syringes marks the final approval for these products as ANDAs or NDAs, so we have achieved our commitment to the FDA that we would get approvals for all of these grandfathered products.

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