FDA – US food and Drug Administration
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
Our STN: BL 125259/98
GlaxoSmithKline Biologicals
Attention: Matthew Whitman
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Mr. Whitman:
We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to add lymphadenopathy to the Adverse Reactions, Postmarketing Experience section of the full prescribing information.