Sanofi (SNY), announced on Friday, that its Nasacort Allergy 24 Hour nasal spray has been approved as an over-the-counter drug.
The nasal spray was approved by the U.S. Food and Drug Administration (FDA) and is the first and only over-the-counter medicine in its class. The FDA approved the medicine based on 13 placebo-controlled efficacy studies, safety information from 43 clinical studies and 16 years of post-marketing surveillance data. Nasacort is a single active ingredient medicine that relieves allergy symptoms for 24 hours with a single dose. About 60 million Americans suffer from nasal allergies a year. These allergies can disrupt sleep, outdoor activities and performance in school and at work. Nasacort is expected to be available over the counter starting in Spring 2014, reports Yahoo.
The FDA is requiring that Nasacort have warnings on its label regarding the risk of growth suppression in children using the product.