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 5 through 65 years of age.
- November 9, 2018 Summary Basis for Regulatory Action - ORALAIR
- November 9, 2018 Approval Letter - ORALAIR
To extend the indication for use in persons 5 - 9 years of age.
- November 9, 2018 Clinical Review Memo - ORALAIR
Statistical Review - ORALAIR
- Statistical Review - ORALAIR, April 7, 2014
- Clinical Review Memo - ORALAIR, March 20, 2014
- Supporting Documents older than three years - ORALAIR