Crysvita

Active Ingredient(s): Burosumab
FDA Approved: * April 17, 2018
Pharm Company: * ULTRAGENYX PHARM INC
Category: Genetic Disorders

Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.[5][8][9] Burosumab was approved by the FDA for its intended purpose, in patients aged one year and older, in April 2018.[10] The FDA approval fell under both the breakthrough therapy and orphan drug designations.[10][11] It was appro... [wikipedia]

* May have multiple approval dates, manufacturers, or labelers.

Dosage List

Crysvita 10 mg/ml Subcutaneous Injection
NDC: 42747-102
Labeler:
Kyowa Kirin, Inc.
Crysvita 30 mg/ml Subcutaneous Injection
NDC: 42747-203
Labeler:
Kyowa Kirin, Inc.
Crysvita 20 mg/ml Subcutaneous Injection
NDC: 42747-304
Labeler:
Kyowa Kirin, Inc.
Crysvita 10 mg/ml Subcutaneous Injection
NDC: 69794-102
Labeler:
Ultragenyx Pharmaceutical Inc.
Crysvita 20 mg/ml Subcutaneous Injection
NDC: 69794-203
Labeler:
Ultragenyx Pharmaceutical Inc.
Crysvita 30 mg/ml Subcutaneous Injection
NDC: 69794-304
Labeler:
Ultragenyx Pharmaceutical Inc.