Palivizumab Product Approval Information - Licensing Action

Proper name: Palivizumab
Tradename: Synagis
Manufacturer: MedImmune, Inc, Gaithersburg, MD, License #1252
Indication for Use: Prophylaxis of serious lower respiratory tract disease, caused by respiratory syncytial virus, in pediatric patients at high risk of RSV disease
Approval Date: 6/19/98
Type of submission: Biologics license application

Approval Letter (PDF)

SBA (PDF)

Reviews (PDF)
   Clinical Review (56 pages)
   CMC Review (27 pages)
   Pharmacology Review (21 pages)
   Product Review (71 pages) - Part III
   Statistical Review (19 pages)