Nasacort Allergy 24HR nasal spray has been approved by the FDA as an over-the-counter (OTC) treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older, according to manufacturer Sanofi. The drug is the first and only medicine in its class to be available without a prescription, according to the company.
“We believe there is significant value in making certain types of medicines, like Nasacort, directly available to consumers,” said Anne Whitaker, president, North America Pharmaceuticals, Sanofi U.S. “Allergy sufferers will benefit from having an additional treatment option and it’s a strong addition to our existing consumer health portfolio.”
According to Sanofi, the FDA approval of Nasacort Allergy 24HR as an OTC treatment was based on data submitted from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance data for Nasacort AQ.
Nasacort will be marketed by Sanofi’s consumer healthcare division, Chattem, Inc, beginning in Spring 2014.