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Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection
RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug
About this update from Amphastar Pharmaceuticals, Inc.
[{"type":"text","content":"RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System. For the past 40 years, the Company has sold and marketed the product under the “grandfather” exception (now termed “unapproved”) to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the Company’s Atropine Sulfate injection for the year ended December 31, 2019 were $12.2 million.Amphastar’s CEO and President, Dr. Jack Zhang, commented: “The FDA’s approval of our Atropine Sulfate product, a product often on the Agency’s Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar’s manufacturing capacity to fulfill such market needs.”Pipeline InformationThe Company currently has four ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.5 billion, three biosimilar products in development targeting products with a market size of approximately $13.0 billion, and nine generic products in development targeting products with a market size of approximately $12.0 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2020. The Company is developing multiple proprietary pipeline products for injectable and intranasal dosage forms, including a new drug application for intranasal naloxone.Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMF, on file with the FDA and is developing several additional DMFs. Company InformationAmphastar is a specialty 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 organizations and drug wholesalers. More information and resources are available at www.amphastar.com.Amphastar’s logo and other trademarks or service marks of Amphastar, including, but not lim...