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Sandoz Strengthens US Respiratory Portfolio with Launch of Generic

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Sandoz has announced the US Food and Drug Administration (FDA) approval and US launch of montelukast sodium, a generic equivalent of leading respiratory medicine SINGULAIR®.

Montelukast sodium is used for the prevention and chronic treatment of asthma in patients two years of age and older, and for the prevention of exercise-induced narrowing of the air passages in patients 15 years of age and older.

It is also used to relieve symptoms of seasonal allergic rhinitis in patients two years of age and older and the symptoms of perennial allergic rhinitis in patients two years of age and older.

“Sandoz is pleased to add montelukast sodium to our growing portfolio of respiratory medicines in the US,” said Don DeGolyer, President of Sandoz US.

DeGolyer continued, “We are committed to expanding our portfolio in this important therapeutic area to provide patients with a growing range of high-quality, affordable treatment options.”

Asthma is one of the leading serious, chronic illnesses among children in the US, and is the third-ranking cause of hospitalizations for children. It also affects nearly 25 million adults. Allergies affect as many as 40 to 50 million Americans.

Merck’s full-year 2011 US sales for SINGULAIR® were approximately USD 3.5 billion.

Sandoz is marketing montelukast sodium in 4 mg and 5 mg strength chewable tablets and in 10 mg strength regular tablets, the same strengths marketed for SINGULAIR® Tablets and SINGULAIR® Chewable Tablets.