DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
Our STN: BL 125259/98
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.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling
How is it possible that Merck has done a study that concludes that HPV4 is not related to autoimmune diseases and yet, GlaxoSmithKline is adding lymphadenopathy, a “disease of the lymph nodes to their labeling?
- Autoimmune etiology: sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis all giving a generalized lymphadenopathy.