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|June 02, 2015 10:00 a.m.|
|Teva Enhances ADHD Product Line with Generic INTUNIV® in the United States|
Teva adds the first nonstimulant therapy to existing line of seven ADHD products
ADHD is the most common neurobehavioral disorder diagnosed in children in
“Guanfacine extended-release tablets join Teva’s current generic line of seven ADHD products,” commented Brendan O’Grady, President and CEO, North America Generic Medicines. “We recognize the need to make affordable generic treatment options available to patients with ADHD.”
INTUNIV® (guanfacine) 1 mg, 2 mg, 3 mg, and 4 mg, had total market sales of approximately
About Guanfacine Extended-Release Tablets
Guanfacine extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. Safety and efficacy of guanfacine extended-release tablets in pediatric patients less than 6 years of age have not been established.
Important Safety Information
Guanfacine extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported.
Treatment with guanfacine extended-release tablets can cause dose-dependent decreases in blood pressure and heart rate. Orthostatic hypotension and syncope have been reported. Somnolence and sedation were commonly reported adverse reactions in clinical studies. The sympatholytic action of guanfacine extended-release tablets may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs.
Most common adverse reactions (≥ 5% and at least twice placebo rate) in clinical trials: somnolence, fatigue, hypotension, nausea, lethargy, abdominal pain, insomnia, dizziness, dry mouth, irritability, vomiting, and bradycardia.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.