Merck announced that the FDA has accepted for review its Biologics License Application (BLA) for investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet. The FDA has already accepted the BLA for Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet on March 27th. Ragweed pollen sublingual allergy immunotherapy tablet is an investigational sublingual dissolvable tablet designed to treat the underlying cause of allergic rhinitis by generating an immune response to help protect against the targeted allergen.

The BLA submission is supported by five studies evaluating the safety and efficacy of ragweed pollen sublingual allergy immunotherapy tablet in adults ≥18 years of age with ragweed induced allergic rhinitis with or without conjunctivitis.

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