Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Pre-Filled Syringes
Amphastar Pharmaceuticals, Inc. (AMPH)
Last amphastar pharmaceuticals, inc. earnings: 3/12 04:05 pm
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Source: Accesswire
RANCHO CUCAMONGA, CA / ACCESSWIRE / August 16, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's New Drug Application ("NDA") for Epinephrine injection USP, 1 mg/10mL (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. For the past 30 years, the Company has sold and marketed Epinephrine injection under the "grandfather" exception to the FDA's "Prescription Drug Wrap-Up" program. Net revenues for the Company's Epinephrine injection for the year ended December 31, 2021, were $27.8 million. Epinephrine injection is the final product that we market under the grandfather exception.Amphastar's CEO and President, Dr. Jack Zhang, commented: "When we went public eight years ago, we had six products which were marketed under the grandfather exception. The approval of epineph
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AMPH
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AMPH
Sec Filings
- 5/10/24 - Form 10-Q
- 5/8/24 - Form 8-K
- 5/2/24 - Form 4
- AMPH's page on the SEC website