On October 11, 2013, the FDA made history by approving Nasacort Allergy 24H, an over-the-counter (OTC) version of the Rx Nasacort AQ (triamcinolone acetonide), a nasally inhaled glucocorticoid for allergy relief. The OTC version is labeled for use in children 2 years of age and older, adolescents and adults.
This product was approved through a prior approval supplement to the original Nasacort AQ NDA. It appears from the supplement approval letter that the OTC version of Nasacort is replacing the Rx version. Thus, with no apparent leave-behind indications or dosing schedule differences for various age groups, the product will only be marketed over-the-counter (labeling for the new product was not yet available on the FDA web site).
Why the surprise? This is not the first time a firm has tried to convince the Agency that a topical nasally inhaled corticosteroid was appropriate for OTC use, but it is the first successful attempt. It has always struck me that, due to a potential for hypothalamic-pituitary-adrenal axis (HPA) suppression and possible slowed rate of growth for children, that FDA would never agree to permit such products in the OTC market. Obviously, the data the firm provided in its supplement and over the years finally convinced the Agency that Nasacort 24H for the approved indication was amenable to self-diagnosis and that the treatment regimen was both safe and effective and could be used appropriately by the general public.
This is not the first OTC surprise for me – I was actually also skeptical that the Agency would approve the OTC overactive bladder treatment patch, Oxytrol for Women due to the potential adverse events that are associated with drugs of this class and the self-diagnosis issue, as well as other issues like drug-drug interactions.
So this is two surprises in the last year or so. Could this signal (as some have postulated) a more gentle approach from FDA when it comes to Rx to OTC switches? Let’s hope my surprise does not translate into significant serious adverse reactions in consumers over time.