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Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Pre-Filled Syringes
RANCHO CUCAMONGA, CA / ACCESSWIRE / August 16, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration
About this update from Amphastar Pharmaceuticals, Inc.
[{"type":"text","content":"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 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.\"Pipeline InformationThe Company currently has three ANDAs on file with the FDA targeting products with a market size of approximately $3.3 billion, three biosimilar products in development targeting products with a market size of approximately $12 billion, and eight generic products in development targeting products with a market size of approximately $9 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2022. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.Company InformationAmphastar is a bio pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizati...