CHICAGO – AltaThera Pharmaceuticals today announced the availability of Sotalol IV (sotalol hydrochloride injection 15mg/mL for intravenous use) in the United States.
The product is the first FDA-approved IV antiarrhythmic introduced in the U.S. market in over 10 years and one of only two FDA-approved antiarrhythmics available in both oral and IV form.
Antiarrhythmics treat irregular, or abnormally fast or slow heartbeats.
Sotalol IV is included in the 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: Adult Advanced Cardiovascular Life Support.
AltaThera President and CEO Brandon Kashfian said the release of Sotalol IV – a multi-year effort that required navigating many hurdles typical in making niche injectable products commercially viable – represents a milestone at the heart of the company’s mission.
“This product fills an unmet medical need in a vulnerable patient population,” Kashfian said. “We did not want to let manufacturing challenges stand in the way of making that happen.”