Sanofi Allergy Drug Safe for Non-prescription Use: FDA Reviewers

July 30, 2013

(Reuters) - Sanofi SA's allergy drug Nasacort AQ is safe enough to be used without a prescription, according to reviewers for the U.S. Food and Drug Administration.

The reviewers, whose opinions were posted on the FDA's website on Monday, said the nasal spray, which currently requires a prescription, "has a favorable risk-benefit profile" for over-the-counter use.

An advisory committee to the FDA is to decide on Wednesday whether to recommend making Nasacort AQ an over-the-counter product. The drug is used to treat hay fever and other respiratory allergies.

Sanofi hopes increased sales of non-prescription and consumer products will help compensate for the loss of sales from prescription products that over time lose patent protection.

Under a 2008 patent settlement, Teva Pharmaceutical Industries Ltd and Barr Pharmaceuticals won the right to sell generic versions of Nasacort AQ. Teva acquired Barr that year for $7.46 billion.

Last year, 1.7 million prescriptions were written for Nasacort AQ and its generics, Sanofi said. Prior to the introduction of generics, Nasacort AQ generated peak annual sales of $375 million. Last year sales were less than $100 million.

If approved, Nasacort AQ would be the first intranasal corticosteroid to be sold over the counter in the United States. It is already sold over the counter in 10 countries.

"We believe that a first-in-class OTC nasal spray has the potential to achieve significant market share during its launch year and beyond," said Jack Cox, a spokesman for Sanofi.


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