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Teva introduces Pulmicort Respules in US market
Jerusalem, Israel | Friday, March 11, 2016, 11:00 Hrs  [IST]

Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, announced the launch of the generic equivalent to Pulmicort Respules (budesonide inhalation suspension), 1 mg/2 ml, 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 suspension—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 $217 million in the United States, according to IMS data as of November 2015.

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.

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.

The most common adverse reactions (incidence = 3 per cent) in clinical trials were: respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.

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