Proper Name: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
Manufacturer: Stallergenes S.A.
- ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.
January 22, 2015 Approval Letter - ORALAIR
To revise the blister and carton labeling with updated safety information.
October 28, 2014 Approval Letter -ORALAIR
To include new safety information on the risk of eosinophilic esophagitis in the Prescribing Information and Medication Guide, has been date stamped and issued.
April 1, 2014 Approval Letter - ORALAIR
The original posted document has been replaced with a revised approval letter to clarify that there were no post-marketing studies not subject to reporting requirements of 21 CFR 601.70.
- Summary Basis for Regulatory Action Template - ORALAIR, March 31, 2014 (PDF - 204KB)
Statistical Review - ORALAIR, April 7, 2014(PDF - 4.4MB) Clinical Review Memo - ORALAIR, March 20, 2014(PDF - 2.7MB)