Dermatophagoides farinae and Dermatophagoides pteronyssinus

FDA Drug Profile — Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus

Drug Details

Generic Name
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Brand Names
Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus
Application Number
BLA101834
Sponsor
Greer Laboratories, Inc.
NDC Codes
1
Dosage Forms
CONCENTRATE
Routes
INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredients
DERMATOPHAGOIDES FARINAE, DERMATOPHAGOIDES PTERONYSSINUS

Indications and Usage

1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity. Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen (1) Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity (1)