Cipla Receives Final Approval for Generic Isoproterenol Hydrochloride Injection

Cipla Ltd. has received final approval for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride Injection USP, 0.2 mg/ml, single-use sterile ampoule from the United States Food and Drug Administration (US FDA). Cipla’s drug is AP-rated generic therapeutic equivalent version of Hospira Inc’s Isuprel Injection, 0.2 mg/ml.

The drug is indicated for the treatment of:

• Mild or transient episodes of heart block that do not require electric shock or pacemaker therapy;

• Serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation);

• Use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available;

• 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.

According to IQVIA, Isuprel Injection and its generic equivalents had US sales of approximately $148-mn for the 12-month period ending April 2018.