Medication Monitor

Generic Name (Trade Name—Company)
June 26, 2018

Isoproterenol hydrochloride injection

(No trade name—Amphastar)
Amphastar announces FDA approval of generic isoproterenol hydrochloride injection

Amphastar announced FDA approval of isoproterenol hydrochloride injection, USP 0.2 mg/mL, 1mL and 0.2 mg/mL, 5-mL single-dose vial, for multiple uses including mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.

The product was determined by FDA to be therapeutically equivalent to Isuprel, which is sold in the United States by Valeant Pharmaceuticals.

Amphastar anticipates launching the product in the third quarter of 2018.