August 21, 2015 Approval Letter with errata - Wilate
August 21, 2015 Approval Letter with errata - Wilate
The original posted document has been replaced with a revised approval letter Pediatric requirements language:
PEDIATRIC 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 pediatric patients 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.