Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Injection
Amphastar Pharmaceuticals, Inc. recently announced the US FDA has granted approval of its Abbreviated New Drug Application (ANDA) for Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) Multiple Dose Vial. Amphastar’s newly approved drug product was determined by the FDA to be therapeutically equivalent to Adrenalin (Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) Multiple Dose Vial) distributed in the US by Par Pharmaceutical, Inc. Epinephrine Injection Multiple Dose Vial is for intramuscular, subcutaneous, and intravenous use, and is indicated for emergency treatment of allergic reactions (Type 1), including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Additionally, the FDA granted 180-day exclusivity to Amphastar as the first generic filer.
Amphastar’s CEO and President, Dr. Jack Zhang, commented “We are pleased about the FDA’s approval of our Epinephrine Injection Multiple Dose Vial, which currently does not have any generic equivalent in the market. This approval expands the product offerings in our generic critical care injectable portfolio and highlights our commitment and internal capability of bringing generic injectable products to the market.”
According to IQVIA, US market annual sales for the 12 months ended December 31, 2019 for Epinephrine Injection, 30 mg/30 mL (1 mg/mL) Multiple Dose Vial was approximately $ 131 million. Amphastar plans to launch this Epinephrine Injection Multiple Dose Vial within 2 to 3 months.
The company currently has six ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.8 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and nine generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2019. 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.
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. For more information, visit www.amphastar.com.
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