ANI Pharmaceuticals announced its partner Pharmaceutics International Inc. (Pii) has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml). ANI plans to launch this currently unavailable drug in December, introducing this critical drug for the treatment of ventricular fibrillation and life-threatening ventricular arrhythmias, such as ventricular tachycardia.
First introduced in 1986, Bretylium Tosylate Injection was added to the Advanced Care Life Support (ACLS) guidelines and algorithms recommended by the American Heart Association (AHA) in the 1990s. Due to raw material shortages, the drug has not been available in the United States since 1999.
Prior to its discontinuation, Bretylium Tosylate was commonly stocked as a standard drug on crash carts. ANI estimates that there are approximately 180,000 crash carts in the U.S. and will recommend at least two vials of Bretylium Tosylate per crash cart.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"We are excited to introduce this important life-saving cardiac drug and provide physicians with another valuable tool to treat patients with ventricular arrhythmias,” Arthur S. Przybyl, ANI's President and CEO said. “ANI will be supporting the launch of this drug with a broad awareness campaign to educate healthcare professionals on the availability, uses and utility of this important drug."
"Partnering with the team at ANI Pharmaceuticals to develop and supply this uniquely effective therapy to health care providers and their patients, is further testament to the value of Pii's Pharmaceutics Know-How™,” Dr. Kurt R. Nielsen, President and CEO of Pii, said. “Pii will exclusively manufacture Bretylium Tosylate Injection, USP, for commercialization by ANI."
Bretylium Tosylate Injection, USP is indicated in the prophylaxis and therapy of ventricular fibrillation. Bretylium Tosylate Injection, USP is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia that have failed to respond to adequate dose of a first-line antiarrhythmic agent, such as lidocaine.
Use of Bretylium Tosylate Injection, USP should be limited to intensive care units, coronary care units or other facilities where equipment and personnel for constant monitoring of cardiac arrhythmias and blood pressure are available.