Nofetumomab Product Approval Information - Licensing Action

Proper name: Nofetumomab
Tradename: Verluma
Manufacturer: Dr. Karl Thomae GmbH, 88397 Biberach/Riss, Germany, License #1199
Indication for Use: Detection of extensive stage disease in patients with biopsy-confirmed, previously untreated, small cell lung cancer
Approval Date: 8/20/96
Type of submission: Biologics license application


Approval Letter (PDF)

Label (PDF)

Reviews (PDF)
    Clinical (40 pages)
    Stability (2 pages)
    Statistical (25 pages)

Page Last Updated: 05/13/2016
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