Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (“FDA”) has granted approval of its abbreviated new drug application (“ANDA”) for Isoproterenol Hydrochloride Injection, USP 0.2mg/mL, 1mL and 0.2mg/mL, 5mL single dose vial. Isoproterenol Hydrochloride is indicated for multiple uses including for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. Amphastar’s newly approved product was determined by the FDA to be therapeutically equivalent to Isuprel® (Isoproterenol Hydrochloride Injection) sold in the United States by Valeant Pharmaceuticals.
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Amphastar's CEO, Dr. Jack Zhang, stated: "We are excited about the FDA approval of Isoproterenol Hydrochloride Injection, which currently only has one other generic vial in the market. This approval further strengthens our vertical integration strategy, given that the Active Pharmaceutical Ingredient for this product is manufactured by Amphastar Nanjing Pharmaceuticals, Co., Ltd., our subsidiary in China."
According to IQVIA, U.S. brand and generic sales of Isoproterenol Hydrochloride Injection, 0.2 mg/mL, 1mL and 0.2mg/mL, 5mL vials and ampules were approximately $147 million for the 12 months ended March 31, 2018.
Amphastar anticipates launching its product in the third quarter of 2018.