Arbor Pharmaceuticals, LLC develops, manufactures, and commercializes prescription products for cardiovascular and pediatric disorders. Its products include Nitrolingual pumpspray for the acute relief of an attack or the prophylaxis of angina pectoris due to coronary artery disease; EDARBI, an angiotensin II receptor blocker for the treatment of hypertension to lower blood pressure; EDARBYCLOR, an angiotensin II receptor blocker and a thiazide-like diuretic drug that is used for the treatment of hypertension to lower blood pressure; BiDil, a prescription drug for heart disease; GLIADEL Wafer, a drug that is used for the treatment of malignant glioma and recurrent glioblastoma multiforme; and...
Six Concourse Parkway
Atlanta, GA 30328
Founded in 2006
Arbor Pharmaceuticals, LLC Announces FDA Approval of Sotylize
Oct 23 14
Arbor Pharmaceuticals, LLC announced 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. 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. Boxed Warning: LIFE THREATENING PROARRHYTHMIA. See full prescribing information for complete boxed warning. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the interval between doses prolonged, or the drug discontinued. Patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance. Contraindications: Sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block unless a functioning pacemaker is present; congenital or acquired long QT syndromes, baseline QT interval >450 ms; cardiogenic shock, uncontrolled heart failure; creatinine clearance <40 mL/min; serum potassium <4 meq/L; bronchial asthma or related bronchospastic conditions; and known hypersensitivity to sotalol. SOTYLIZE may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of SOTYLIZE including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Additionally, because sotalol can cause life-threatening ventricular arrhythmias, reserve it for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE. QT Prolongation and Proarrhythmia: SOTYLIZE can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. The use of SOTYLIZE in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended. Adverse Reactions: The most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, bradycardia, dizziness, and headache. Drug Interactions: Digoxin increases the risk of proarrhythmic events; calcium blocking drugs may have additive effects on decreasing atrioventricular conduction, ventricular function, and blood pressure; concomitant use of catecholamine-depleting drugs may produce hypotension, marked bradycardia, and syncope; dosage of insulin or antidiabetic drugs may require adjustment; dose of beta-2 receptor agonists may have to be increased; sotalol may potentiate rebound hypertension after discontinuation of clonidine; and Aluminum or magnesium-based antacids reduce sotalol exposure.
Arbor Pharmaceuticals Reportedly Explores $1 Billion Plus Sale
Oct 2 14
Arbor Pharmaceuticals, LLC is reportedly exploring a sale that could fetch more than $1 billion. Arbor Pharmaceuticals is working with JPMorgan Chase on the potential sale, the people with knowledge of the situation said on Thursday, asking not to be named because the discussions are private.
Arbor Pharmaceuticals, LLC Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014
Sep 10 14
Arbor Pharmaceuticals, LLC Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014 . Venue: Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA 02116, United States.