WASHINGTON, July 29 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
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
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
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
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.