ATGAM
STN: 103676
Proper Name: lymphocyte immune globulin,anti-thymocyte globulin[equine])
Tradename: ATGAM
Manufacturer: Pharmacia & Upjohn Company LLC, a Pfizer company
Indications:
- Renal transplant rejection.
- Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation.
- Limitations of Use:
The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi’s syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.
Product Information
Supporting Documents
- August 23, 2023 Approval Letter - ATGAM
- Clinical Pharmacology Review - ATGAM
- May 2, 2023 Approval Letter - ATGAM
- May 1, 2023 Clinical Review Memo - ATGAM