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  1. Center for Biologics Evaluation and Research (CBER)

List of Determinations Made by CBER Including Written Request

Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85) and BPCI Act (sections 7001 through 7003 of the Patient Protection and Affordable Care Act (P.L. 111-148)), the following list identifies those approved biological products for which a pediatric exclusivity determination was made, on or after March 23, 2010.

In addition, it provides a link to a copy of the Written Request and any amendments.

NOTE: Only applications held by the identified sponsor were granted pediatric exclusivity.  We will update this page each time a determination is made.

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

List of Determinations Made by CBER Including Written Request

Biological Product Sponsor Determination Date Written Request and Related Documents
tisagenlecleucel Novartis 6/12/2017 December 1, 2016 Written Request
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