Drugs

List of Determinations 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)

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.  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.

The administrative amendments issued during the summer of 2002 and spring of 2004, which cover the passage of the Best Pharmaceuticals for Children Act on January 4, 2002, and the requirement for submitted reports to include more specific information on racial and ethnic minorities, respectively, may not be listed below for original Written Requests that predate their release (e.g., bicalutamide).

N=64

DrugSponsorDetermination DateWritten Request and Related Documents
AlbuterolGlaxoSmithKline8/27/2008
AlfuzosinSanofi Aventis9/7/2010
AlmotriptanJohnson & Johnson Pharmaceutical Research & Development1/13/2009
AnastrozoleAstraZeneca11/14/2007
AripiprazoleOtsuka11/14/2007
BendamustineCephalon5/24/2012
BicalutamideAstraZeneca9/19/2008
BivalirudinThe Medicines Company6/17/2009
CandesartanAstraZeneca Pharmaceuticals LP7/20/2009
CapecitabineHoffman-La Roche, Inc.8/28/2013
CaspofunginMerck & Co., Inc.4/15/2008
ClopidogrelSanofi Aventis1/20/2011
ColesevelamDaiichi Sankyo Pharma2/17/2009
DarunavirTibotec6/7/2011
DexmedetomidineHospira3/12/2013
DifluprednateAlcon3/21/2013
DocetaxelSanofi Aventis3/17/2010
DuloxetineEli Lilly7/2/2012
EfavirenzBMS1/29/2013
EntecavirBMS12/5/2013
EplerenonePfizer10/24/2007
EsomeprazoleAstraZeneca LP5/1/2009
EszopicloneSunovion6/29/2012
EverolimusNovartis7/10/2012
EzetimibeSchering Corporation2/14/2008
FamciclovirNovartis9/21/2009
Finafloxacin New!Alcon8/25/2014
FosamprenavirViiV Healthcare1/10/2012
FulvestrantAstraZeneca2/1/2011
GatifloxacinAllergan5/19/2009
Ixabepilone BMS4/5/2011
LansoprazoleTap Pharmaceutical Products, Inc.7/15/2008
LevetiracetamUCB, Inc.6/3/2008
LevocetirizineUCB, Inc.8/25/2009
Loteprednol/TobramycinBausch & Lomb12/28/2010
Lopinavir/RitonavirAbbott Laboratories3/7/2008
MemantineForest Labs6/16/2014
Nitric OxideINO Therapeutics11/2/2010
OlmesartanDaiichi Sankyo10/7/2009
OlopatadineAlcon Research, Ltd.8/12/2009
PaliperidoneOrtho-McNeil-Janssen Pharmaceuticals, Inc.1/5/2011
Palonosetron Helsinn4/10/2014
PantoprazoleWyeth Pharmaceuticals, Inc.2/17/2009
PemetrexedEli Lilly12/3/2010
QuetiapineAstraZeneca Pharmaceuticals LP1/23/2009
RabeprazoleEisai12/4/2012
RisedronateProcter & Gamble Pharmaceuticals, Inc.4/24/2009
RizatriptanMerck9/20/2011
RocuroniumOrganon, Inc.4/3/2008
RosuvastatinAstraZeneca Pharmaceuticals LP7/7/2009
SapropterinBioMarin3/13/2014
SaquinavirHoffman-La Roche, Inc.10/26/2010
SildenafilPfizer2/9/2012
TamsulosinBoehringer Ingelheim9/17/2009
Technetium Tc99 sestamibiBMS1/11/2008
TemsirolimusPfizer2/28/2012
TenofovirGilead Sciences, Inc.9/6/2011
TipranavirBoehringer Ingelheim Pharmaceuticals, Inc.3/7/2008
TopiramateOrtho-McNeil-Janssen Pharmaceuticals, Inc.7/24/2008
ValacyclovirGlaxoSmithKline2/28/2008
ValganciclovirHoffman-La Roche Inc.7/24/2008
ValproateAbbott12/14/2007
VigabatrinLundbeck10/3/2013
Zoledronic acidNovartis12/21/2007

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