Amphastar receives FDA nod for generic Adrenalin

Adults who need emergency treatment for certain allergic reactions will soon have a new generic treatment option. Amphastar has received the Food and Drug Administration’s blessing for epinephrine injection in a 30 mg/30 ml (1 mg/ml) multiple dose vial.

Amphastar's product is the first generic of Par’s Adrenalin (epinephrine injection) 30 mg/30 ml (1 mg/ml) multiple dose vial.

The product, which is for intramuscular, subcutaneous and intravenous use, is indicated for emergency treatment of Type 1 allergic reactions, including anaphylaxis, as well as to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

“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,” said Amphastar CEO and president Jack Zhang. "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."

The product has a market value of roughly $131 million for the 12 months ended Dec. 31, 2019, according to IQVIA.

Amphastar plans to launch its epinephrine injection multiple dose vial within two to three months.