Amring gets FDA blessing for generic Isuprel

Amring has obtained the Food and Drug Administration’s clearance for generic isoproterenol hydrochloride, (0.2 mg/ml), which is the generic of Isuprel.

The product is available as 1-ml or 5-ml single-dose vials.

Isoproterenol hydrochloride injection is indicated for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy; for serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation); for use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available; for bronchospasm occurring during anesthesia; and as an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.

"We are pleased to add Isoproterenol Hydrochloride Injection USP to our generics portfolio, this product brings long-term value to patients and customers in our target markets,” said Daniel Carbery, president and CEO of Amring. “We look forward to realizing the benefits of this, and other product launches and future business development activities in 2021.”