Merck’s Singulair is a respiratory pill that is currently only available through prescription. The pill works to help treat people with allergies and asthma. If the drug were to go OTC, it would only be marketed to adults and would only be advised for use against allergies, reports the Associated Press.
However, the FDA is worried that Singulair will be used by children despite being labelled for adults. Another concern that the FDA has is that it will be bought as an OTC treatment for asthma. Merck doesn’t have plans to sell the drug as an OTC solution to asthma and instead says it only want to offer it as an alternative to other OTC allergy medications, the Associated Press notes.
Merck’s desire for Singulair to enter the OTC market is similar to efforts made by Sanofi (SNY) last year. Sanofi got approval from the FDA to release its Nasacort Allergy 24 Hour nasal spray as an OTC drug last year. Nasacort was allowed to go OTC so long as its label included a warning that children using the product could experience growth suppression.