Our STN: BL 125127/319
Attention: Judith Magner, MS
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Magner:
This is a clarification to your approval letter of October 19, 2009, regarding the pediatric study fulfillment requirements.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in the pediatric age group unless this requirement is waived, deferred, or inapplicable.
We note that you have fulfilled the pediatric study requirement for all relevant pediatric age groups for this application.
We are waiving the pediatric study requirement for ages birth to < 6 months of age because necessary studies in this age group are impossible or highly impracticable and there is evidence strongly suggesting that Fluarix® would be ineffective in this pediatric group.
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