Overview
Dermatophagoides pteronyssinus extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. This combination is approved for as a year-round, once-a-day tablet that's dissolved under the tongue as a treatment for dust mite allergies.
Background
Dermatophagoides pteronyssinus extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. This combination is approved for as a year-round, once-a-day tablet that's dissolved under the tongue as a treatment for dust mite allergies.
Indication
Dermatophagoides pteronyssinus is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. It is approved for use in patients 12 through 65 years of age.
Associated Conditions
- House Dust Mite Allergy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 3 | Not yet recruiting | |||
2019/09/24 | Phase 4 | Completed | |||
2011/02/08 | Not Applicable | Completed | Beijing Tongren Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Antigen Laboratories, Inc. | 49288-0854 | SUBCUTANEOUS, INTRADERMAL | 1000 [AU] in 1 mL | 5/11/2012 | |
| Antigen Laboratories, Inc. | 49288-0762 | SUBCUTANEOUS, INTRADERMAL | 16 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0786 | SUBCUTANEOUS, INTRADERMAL | 400 [AU] in 1 mL | 6/17/2010 | |
| Antigen Laboratories, Inc. | 49288-0736 | SUBCUTANEOUS, INTRADERMAL | 400 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0708 | SUBCUTANEOUS, INTRADERMAL | 833.33 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0765 | SUBCUTANEOUS, INTRADERMAL | 400 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0657 | SUBCUTANEOUS, INTRADERMAL | 1000 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0780 | SUBCUTANEOUS, INTRADERMAL | 16 [AU] in 1 mL | 4/26/2010 | |
| Antigen Laboratories, Inc. | 49288-0705 | SUBCUTANEOUS, INTRADERMAL | 166.67 [AU] in 1 mL | 12/2/2009 | |
| Antigen Laboratories, Inc. | 49288-0840 | INTRADERMAL, SUBCUTANEOUS | 2000 [AU] in 1 mL | 3/23/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||