- Generic drugmaker Amphastar Pharmaceuticals ( NASDAQ: AMPH ) announced Tuesday that the U.S. Food and Drug Administration (FDA) approved its New Drug Application ("NDA") for an Epinephrine injection marketed as a single dose pre-filled syringe.
- Epinephrine injection is used to raise arterial blood pressure in adults who experience hypotension linked to septic shock.
- The company said that the Epinephrine injection, which generated $27.8M in net revenue for 2021, was available in the market for the past 30 years under the "grandfather" exception to the FDA's "Prescription Drug Wrap-Up" program.
- "When we went public eight years ago, we had six products which were marketed under the grandfather exception," Amphastar ( AMPH ) Chief Executive Jack Zhang. Epinephrine injection marks the final product the company marketed under the grandfather exception.
- Last week, AMPH exceeded Street forecasts with its Q2 2022 financials.
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Amphastar wins FDA approval for Epinephrine pre-filled syringes