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Amphastar Announces the Receipt of a MINOR CRL for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial
RANCHO CUCAMONGA, Calif., Jan. 28, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that on January 24, 2020, the U.S. Food
About this update from Amphastar Pharmaceuticals, Inc.
[{"type":"text","content":"RANCHO CUCAMONGA, Calif., Jan. 28, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that on January 24, 2020, the U.S. Food and Drug Administration (“FDA”) issued a “MINOR” Complete Response Letter (“CRL”) for its Abbreviated New Drug Application (“ANDA”) for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose. Amphastar responded to the MINOR CRL on January 27, 2020, and expects a decision from the FDA within three months.\n Pipeline Information The Company currently has five ANDAs, filed with the FDA targeting products with a market size of approximately $1.1 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and 11 generic products in development targeting products with a market size of approximately $13 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2019. The Company’s proprietary pipeline includes a new drug application for intranasal naloxone. The Company is currently developing three other proprietary products, which include injectable and intranasal dosage forms. Company Information Amphastar 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 limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar. Forward Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share ...