FDA Approves First Generic of Isuprel, the Subject of a Price-Hike Outcry

Nexus Pharmaceuticals version gets priority attention

The FDA has approved the first generic version of isoproterenol hydrochloride injection (Isuprel, Valeant) , a drug that helped fuel debate over drug costs when Valeant raised the price more than 300%, to $881 per vial, after buying the six-decade-old drug in 2015.

Nexus Pharmaceuticals' isoproterenol hydrochloride injection received expedited review as a potential first generic. FDA prioritizes the review of potential first generics, which can open the market to competition and drive down prices. The Nexus drug is available as a single-dose vial containing 0.2 mg per 1 mL or 1 mg/5 mL and is an AP Rated generic equivalent of Isuprel.

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.

Valeant’s Isuprel—a medication first approved in 1956—took in $150 million last year, according to FiercePharma. Isuprel and Nitropress, another hospital-administered heart medication that Valeant purchased from Marathon Pharmaceuticals in 2015, became the focus of a Congressional pricing investigation and a part of the pricing firestorm that continues today. After buying the medication, Valeant jacked up their prices by several hundred percent.

Sources: FDA; August 8, 2017; Nexus Pharmaceuticals; August 3, 2017; FiercePharma; August 7, 2017.