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FDA approves new allergy treatment aerosol

JERUSALEM -- A new allergy treatment aerosol was approved this week by the U.S. Food and Drug Administration (FDA). QNASLTM, a "dry" nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms, will be available by prescription in April 2012.

QNASLTM can be used by adults and adolescents 12 years of age and older. This environmentally friendly treatment is a once-daily, pressurized, HFA-propelled nonaqueous aerosol which also offers a built-in dose counter.

Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, manufactures QNASLTM. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.

The approval of QNASLTM Nasal Aerosol is based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adolescent and adult patients 12 years of age and older.

"There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies," said Gary N. Gross, MD, FACAAI, practicing allergist and co-founder of the Dallas Asthma and Allergy Center. "The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery."

Allergic rhinitis (AR) is the most common allergic disease in the U.S., affecting between 10 to 30 percent of adults and adolescents. It affects more than one in five people, causing some to have symptoms year round (PAR) and others to experience symptoms during specific times of the year (SAR), such as spring or fall.

"Given the number of people living with allergic rhinitis who are still seeking adequate relief, the availability of a new dry nasal aerosol is very welcome news," said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA). "Seasonal and perennial allergies can have a significant impact on a person's quality of life and we commend Teva for providing patients with a great new option that expands access to quality care."

"The approval of QNASL is a significant milestone for Teva Respiratory and represents our commitment to addressing the unmet needs of millions of Americans suffering from allergic rhinitis," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "We are committed to the development of new options for treatment of respiratory diseases that meet patients' needs."

Published March 28, 2012

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