Proper Name: Short Ragweed Pollen Allergen Extract
Manufacturer: Merck Sharp & Dohme Corp
- Immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen approved for use in adults 18 through 65 years of age.
May 20, 2016 Approval Letter - RAGWITEK(PDF - 27KB)
To include glossodynia in Section 6.2, Postmarketing Experience, of the package insert.
February 10, 2015 Approval Letter - RAGWITEK
To include language regarding concomitant dosing with other allergen immunotherapy to the “What Should I Tell My Doctor Before Taking RAGWITEK?” section of the US Medication Guide.
July 16, 2014 Approval Letter - RAGWITEK
To include changes regarding the number and percentage of subjects who completed twelve weeks of treatment in section 6.1 of the package insert.
April 17, 2014 Approval Letter - RAGWITEK April 16, 2014 Summary Basis for Regulatory Action - RAGWITEK(PDF - 166KB) Approval History, Letters, Reviews, and Related Documents - RAGWITEK
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.