Inspire Pharmaceuticals has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).
The FDA has placed erythromycin ophthalmic ointment on the FDA’s Drug Shortage list. The Centers for Disease Control and Prevention (CDC), the US Department of Health and Human Services, the American Academy of Ophthalmology and the FDA all recommend that existing supplies of erythromycin ophthalmic ointment be reserved for the treatment of neonatal prophylaxis use.
In connection to that the CDC has recommended AzaSite as an acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic ointment is not available.
Reportedly, AzaSite has not been approved by the FDA for the treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have been conducted using AzaSite in this population. The recommendation was based on available AzaSite data on pharmcology and gonococcal microbiologic sensitivity.