The US FDA has approved Teva Pharmaceutical's QNASL nasal aerosol a dry nasal aerosol corticosteroid to treat seasonal nasal and year-round nasal allergy symptoms in adults and adolescents.
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QNASL is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly and offers a built-in dose counter.
The company plans to market the nonaqueous or dry nasal aerosol in a product category that reports annual sales of $2.5bn.
The product is expected to be available by prescription in April 2012, the company said.
The safety and efficacy of QNASL nasal aerosol was demonstrated in four, Phase III randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials.
Teva Global Respiratory Research and Development senior vice president Tushar Shah said the approval of QNASL is a significant milestone for Teva Respiratory.
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