Amphastar Announces the Receipt of a MINOR CRL for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial
January 28, 2020 at 04:05 pm
Share
Amphastar Pharmaceuticals, Inc. announced that on January 24, 2020, the U.S. Food and Drug Administration 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. 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.
Amphastar Pharmaceuticals, Inc. is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and injectable, inhalation, and intranasal products. Additionally, it sells insulin API products. Most of its finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. Its segments include finished pharmaceutical products and API products. The finished pharmaceutical products segment manufactures, markets and distributes Primatene MIST, epinephrine, glucagon, phytonadione, lidocaine, enoxaparin, naloxone, as well as various other critical and non-critical care drugs. The API segment manufactures and distributes RHI API and porcine insulin API for external customers and internal product development. Its pipeline has over 20 product candidates, including generic ANDAs, biosimilar, and others.
AMPHASTAR PHARMACEUTICALS, INC. 
