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U.S. Department of Health and Human Services

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Oprelvekin Product Approval Information - Licensing Action

Proper name: Oprelvekin
Tradename: Neumega
Manufacturer: Genetics Institute, Inc, Andover, MA, License #1163
Indication for Use: Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia
Approval Date: 11/25/97
Type of submission: Biologics license application

 


Approval Letter - (PDF)

Reviews - (PDF)
    Clinical (54 pages)
    Clinical pharmacokinetic (17 pages)
    CMC 1 (4 pages)
    CMC 2 (3 pages)
    Pharmacology (56 pages)
    Statistical (33 pages)