Arbor Pharmaceuticals Announces FDA approval of Sotylize
Friday, October 24, 2014
Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Sotylize is the first and only sotalol oral solution indicated for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter.
Prior to the approval of Sotylize, sotalol was only available in tablet form. The tablet form of the product is commonly compounded by pharmacists into a liquid suspension using simple syrup for pediatric and elderly patients who cannot swallow pills. It is such a common practice that the FDA changed the tablet labeling to include instructions for pharmacists on how to compound a simple syrup based sotalol suspension.
Ed Schutter, President & CEO of Arbor stated, "I am pleased that Arbor''s second internally developed NDA was approved in a timely fashion prior to our PDUFA date. We feel that a stable homogenous solution form of sotalol will provide an important treatment option for appropriate patients. Sotylize adds to our growing portfolio of now seventeen different approved prescription products that may help to improve the lives of our patients."
Dr. Laurence Downey, VP of Medical & Scientific Affairs added, "We are proud to have our second NDA approval in the very short history of our company. Sotylize will play an important role in facilitating how this important drug is administered to patients with serious cardiac conditions.''
Arbor Pharmaceuticals will launch Sotylize in the first quarter of 2015.
SOTYLIZE (sotalol hydrochloride) is an antiarrhythmic indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening and for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.
Source : http://arborpharma.com
