FDA panel recommends over-the-counter use of Sanofi allergy drug
WASHINGTON (Reuters) - Sanofi SA's allergy drug Nasacort AQ is safe enough to be used without a prescription, a panel of advisors to the U.S. Food and Drug Administration ruled on Wednesday.
The panel voted 10-6 in favor of allowing the drug to be made available over-the-counter. There were two abstentions. The drug is used to treat hay fever and other respiratory allergies.
The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
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.
"Today's positive vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," Dr. Charles Hugh-Jones, chief medical officer for the French company's U.S. operations said.
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.
(Reporting by Toni Clarke in Washington; Editing by Carol Bishopric)