US finished-dose generic drug company Vitruvias Therapeutics and Chinese pharma company Sinotherapeutics have announced the US launch of a bioequivalent FDA-approved version of antiarrhythmic drug Rythmol SR, known generically as propafenone hydrochloride.
Rythmol SR, which is an oral administered drug, is supplied in extended-release capsules of 225, 325 and 425 mg. The antiarrhythmic drug is approved for the treatment of sustained ventricular tachycardia, which is considered to be life-threatening.
According to Vitruvias Therapeutics, dosage of Rythmol SR should be initiated in the hospital setting.
Rythmol SR is also approved for the conversion to and/or maintenance of sinus rhythm in patients suffering from supraventricular arrhythmias without structural heart disease and for the maintenance of sinus rhythm in patients having paroxysmal atrial fibrillation or atrial flutter associated with disabling symptoms.
Dr. Jason Wan – Founder and CEO of Sinotherapeutics said: “We are pleased that we found Vitruvias. Like us, they are a young company, but they are growing rapidly through hard work, dedication and persistence in what is a very difficult U.S. market.
“We are confident they will maximize the value of our asset and we look forward to their future participation with other products in our very robust pipeline.”
Carl Whatley – Chairman and CEO of Vitruvias said: “We are pleased to have found a Chinese partner with the resources and technical skills to formulate these high-barrier generics. Dr. Wan has put together a tremendous team in Shanghai and they are in the process of filing their many high-barrier ANDAs in the pipeline.”