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|March 09, 2016 11:33 a.m.|
|Teva Completes Generic Pulmicort® Respules Portfolio with the Launch of Third Strength in the United States|
Budesonide inhalation suspension is an inhaled corticosteroid medicine. It is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. Budesonide inhalation suspension helps to reduce swelling and inflammation in the lungs, and also helps keep the airways open to reduce asthma symptoms.
With the addition of this new strength of budesonide inhalation suspension, Teva—the leader of the product market in total prescriptions of budesonide inhalation suspension2—now offers the complete family of all strengths including, 0.25 mg/2 mL, 0.5 mg/2 mL, and 1 mg/2 mL.
Pulmicort Respules® (budesonide inhalation suspension), had
annual sales of approximately
About Budesonide Inhalation Suspension
Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Budesonide inhalation suspension is not indicated for the relief of acute bronchospasm.
Important Safety Information
The use of budesonide inhalation suspension is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Budesonide inhalation suspension is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension.
Systemic and inhaled corticosteroid use may result in the following serious adverse reactions: Candida albicans infection; hypersensitivity reactions, including anaphylaxis; immunosuppression; hypercorticism and adrenal suppression; reduction in bone mineral density; growth effects in pediatric patients; glaucoma, increased intraocular pressure and cataracts; and eosinophilic conditions and Churg-Strauss syndrome.
The most common adverse reactions (incidence ≥ 3%) in clinical trials were: respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.
For more information, please see the accompanying Full Prescribing Information.
1 Pulmicort Respules® is a registered trademark of
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 specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of
Teva Pharmaceutical Industries Ltd.