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Allergen immunotherapy / Allergic rhinitis / Allergen / Allergy / Sublingual administration / Immunotherapy / Timothy-grass / Allergic conjunctivitis / Pollen / Medicine / Allergology / Immunology


Summary Basis for Regulatory Action Date: April 11, 2014 From: Jon R. Daugherty, Ph.D., Chair of the Review Committee BLA/STN#: [removed]Applicant Name: Merck Sharp & Dohme Corporation Date of Submission: January 25, 2013
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City

Swindon / Gelatin / /

Company

Merck & Co. Inc. / Drug Product Manufacturing / Primary Packaging / Catalent Pharma Solutions Limited / Release/Stability Testing ALK-Abelló A/S / Merck / Drug Substance Manufacturing / Merck Sharp & Dohme Corporation / Release Testing Catalent Pharma Solutions Limited / Catalent Pharma Limited / /

Continent

Europe / /

Country

United States / United Kingdom / /

Event

FDA Phase / /

Facility

Laboratory of Immunobiochemistry / Promotional Labeling Review Toxicology Review Toxicology Review Facility / Catalent Pharma Solutions Limited facility / /

IndustryTerm

drug solution / tablet formulation technology / treatment of allergic diseases / allergenic products / healthcare setting / /

MedicalCondition

aluminum blister / serious allergic reactions / conjunctivitis / anaphylactic reactions / severe allergic reactions / final blister / allergic diseases / disease / eosinophilic esophagitis / sealed blister / allergy / blister / each final DP blister / Bioequivalent allergy units / /

MedicalTreatment

immunotherapy / allergen immunotherapy / pharmacotherapy / /

Organization

Approval Offices Signatory Authority / Laboratory of Immunobiochemistry / FDA / Allergenic Products Advisory Committee / /

Person

Timothy Grass / Steven Kunder / D. Craig E. Zinderman / Lot Release Testing / M.D. Taruna Khurana / Ronald L. Rabin / James Kenney / Marion F. Gruber / Kristine T. Khuc / May / Patricia Rohan M.D. Craig / Nabil Al-Humadi / Deborah Trout April / M.D. Tammy Massie / Daphne D. Stewart / Lot Release / Lillian Ortega April / Jon R. Daugherty / /

Position

physician / Director / Office / Chair of the Review Committee / /

Product

Presentation GRASTEK tablets / mannitol / Sublingual Tablets / GRASTEK Final DP Tablets INGREDIENT FUNCTION QUANTITY PER TABLET / epinephrine / GRASTEK tablets / GRASTEK Sublingual Tablet / This / GRASTEK / GRASTEK® Established Name / DP / /

ProvinceOrState

Indiana / Newfoundland / /

PublishedMedium

the Medication Guide / /

Technology

antibodies / tablet formulation technology / /

SocialTag