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 Approval History, Letters, Reviews, and Related Documents - RAGWITEK[ARCHIVED]
FDA approves Ragwitek for short ragweed pollen allergies
Press Release: 4/17/2014
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