List of Determinations Including Written Request

/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM332907.pdf

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.

N=54

Drug	Sponsor	Determination Date	Written Request and Related Documents
Albuterol	GlaxoSmithKline	8/27/2008	Written Request [PDF -337KB] Amendment 1 [PDF -547KB] Amendment 2 [PDF -172KB] Amendment 3 [PDF -204KB] Amendment 4 [PDF -467KB]
Alfuzosin	Sanofi Aventis	9/7/2010	Written Request [PDF -207KB] Amendment 1 [PDF -58KB] Amendment 2 [PDF -267KB]
Almotriptan	Johnson & Johnson Pharmaceutical Research & Development	1/13/2009	Written Request [PDF -197KB] Reissue [PDF -102KB]
Anastrozole	AstraZeneca	11/14/2007	Written Request - Amendment 4 [PDF -416KB]
Aripiprazole	Otsuka	11/14/2007	Written Request [PDF -499KB]
Bendamustine	Cephalon	5/24/2012	Written Request [PDF -116KB] Amendment 1 [PDF -159KB] Amendment 2 [PDF -113KB]
Bicalutamide	AstraZeneca	9/19/2008	Written Request [PDF -256KB] Amendment 1 [PDF -264KB] Amendment 2 [PDF -236KB] Amendment 3 [PDF -185KB] Amendment 4 [PDF -297KB] Amendment 5 [PDF -182KB]
Bivalirudin	The Medicines Company	6/17/2009	Written Request [PDF -504KB]
Candesartan	AstraZeneca Pharmaceuticals LP	7/20/2009	Written Request [PDF -240KB] Amendment 1 [PDF -215KB] Amendment 2 [PDF -254KB] Amendment 3 [PDF -155KB] Amendment 4 [PDF -145KB] Amendment 5 [PDF -176 KB]
Caspofungin	Merck & Co., Inc.	4/15/2008	Written Request - Amendment 4 [PDF -91KB]
Clopidogrel	Sanofi Aventis	1/20/2011	Written Request [PDF -172KB] Amendment 1 [PDF -116KB]
Colesevelam	Daiichi Sankyo Pharma	2/17/2009	Written Request [PDF -208KB] Amendment 1 [PDF -112KB] Amendment 2 [PDF -69KB] Amendment 3 [PDF -115KB]
Darunavir	Tibotec	6/7/2011	Written Request [PDF -101KB] Amendment 1 [PDF -102KB]
Docetaxel	Sanofi Aventis	3/17/2010	Written Request [PDF -126KB]
Duloxetine	Eli Lilly	7/2/2012	Written Request [PDF -76KB] Amendment 1 [PDF -151KB] Amendment 2 [PDF -145KB]
Eplerenone	Pfizer	10/24/2007	Written Request [PDF -425KB] Amendment 1 [PDF -403KB] Amendment 2 [PDF -143KB] Amendment 3 [PDF -114KB] Memo to File [PDF -12KB]
Esomeprazole	AstraZeneca LP	5/1/2009	Written Request [PDF -243KB] Amendment 1 [PDF -235KB] Amendment 2 [PDF -235KB] Amendment 3 [PDF -242KB] Amendment 4 [PDF -249KB]
Eszopiclone	Sunovion	6/29/2012	Written Request [PDF -217KB] Amendment 1 [PDF -245KB]
Everolimus	Novartis	7/10/2012	Written Request [PDF -145KB]
Ezetimibe	Schering Corporation	2/14/2008	Written Request - Amendment 1 [PDF -220KB]
Famciclovir	Novartis	9/21/2009	Written Request [PDF -166KB] Amendment 1 [PDF -177KB] Amendment 2 [PDF -106KB] Amendment 3 [PDF -107KB]
Fosamprenavir	ViiV Healthcare	1/10/2012	Written Request [PDF -173KB] Amendment 1 [PDF -133KB] Amendment 2 [PDF -167KB] Amendment 3 [PDF -57KB] Amendment 4 [PDF -109KB] Amendment 5 [PDF -115KB]
Fulvestrant	AstraZeneca	2/1/2011	Written Request [PDF -62KB] Amendment 1 [PDF -63KB]
Gatifloxacin	Allergan	5/19/2009	Written Request [PDF -150KB] Amendment 1 [PDF - 63KB]
Ixabepilone	BMS	4/5/2011	Written Request [PDF -69KB] Amendment 1 [PDF - 91KB] Amendment 2 [PDF - 135KB]
Lansoprazole	Tap Pharmaceutical Products, Inc.	7/15/2008	Written Request [PDF -335KB] Amendment 1 [PDF -276KB] Amendment 2 [PDF -144KB] Amendment 3 [PDF -182KB] Amendment 4 [PDF -519KB]
Levetiracetam	UCB, Inc.	6/3/2008	Written Request [PDF -44KB] Amendment 1 [PDF -24KB] Reissue 1 [PDF -27KB] Reissue 2 [PDF -31KB] Amendment 2 [PDF -25KB] Amendment 3 [PDF -34KB]
Levocetirizine	UCB, Inc.	8/25/2009	Written Request [PDF -155KB]
Loteprednol/Tobramycin	Bausch & Lomb	12/28/2010	Written Request [PDF -43KB] Amendment 1 [PDF -25KB]
Lopinavir/Ritonavir	Abbott Laboratories	3/7/2008	Written Request [PDF -151KB] Amendment 1 [PDF -125KB] Amendment 2 [PDF -125KB] Amendment 3 [PDF -128KB] Amendment 4 [PDF -165KB] Amendment 5 [PDF -58KB] Amendment 6 [PDF -65KB]
Nitric Oxide	INO Therapeutics	11/2/2010	Written Request [PDF -117KB]
Olmesartan	Daiichi Sankyo	10/7/2009	Written Request [PDF - 29KB] Amendment 1 [PDF -271KB] Reissue [PDF -130KB]
Olopatadine	Alcon Research, Ltd.	8/12/2009	Written Request [PDF -49KB]
Paliperidone	Ortho-McNeil-Janssen Pharmaceuticals, Inc.	1/5/2011	Written Request [PDF -72KB] Amendment 1 [PDF -40KB] Amendment 2 [PDF -103KB]
Pantoprazole	Wyeth Pharmaceuticals, Inc.	2/17/2009	Written Request [PDF -247KB] Amendment 1 [PDF -182KB] Amendment 2 [PDF -139KB] Amendment 3 [PDF -228KB] Amendment 4 [PDF -237KB]
Pemetrexed	Eli Lilly	12/3/2010	Written Request [PDF -223KB] Amendment 1 [PDF -163KB] Amendment 2 [PDF -80KB] Amendment 3 [PDF -110KB]
Quetiapine	AstraZeneca Pharmaceuticals LP	1/23/2009	Written Request [PDF -263KB] Amendment 1 [PDF -263KB]
Rabeprazole	Eisai	12/4/2012	Written Request [PDF -230KB] Amendment 1 [PDF -173KB] Amendment 2 [PDF -39KB] Amendment 3 [PDF -239KB] Amendment 4 [PDF -223KB] Amendment 5 [PDF -234KB] Amendment 6 [PDF -317KB]
Risedronate	Procter & Gamble Pharmaceuticals, Inc.	4/24/2009	Written Request [PDF -186KB] Amendment 1 [PDF -173KB] Amendment 2 [PDF -190KB]
Rizatriptan	Merck	9/20/2011	Written Request [PDF -77KB] Amendment 1 [PDF -113KB]
Rocuronium	Organon, Inc.	4/3/2008	Written Request - Amendment 6 [PDF -68KB]
Rosuvastatin	AstraZeneca Pharmaceuticals LP	7/7/2009	Written Request [PDF -160KB]
Saquinavir	Hoffman-La Roche, Inc.	10/26/2010	Written Request [PDF -159KB] [*note for vision impaired users] Amendment 1 [PDF -107KB] Amendment 2 [PDF -77KB] Reissue [PDF -654KB] Reissue Amendment 1 [PDF -128KB] Reissue Amendment 2 [PDF -103KB]
Sildenafil	Pfizer	2/9/2012	Written Request [PDF -107KB] Amendment 1 [PDF -220KB] Amendment 2 [PDF -233KB] Amendment 3 [PDF -90KB] Amendment 4 [PDF -117KB] Amendment 5 [PDF -120KB] Amendment 6 [PDF -159KB]
Tamsulosin	Boehringer Ingelheim	9/17/2009	Written Request [PDF -133KB] Amendment 1 [PDF -50KB] Amendment 2 [PDF -68KB] Amendment 3 [PDF -80KB]
Technetium Tc99 sestamibi	BMS	1/11/2008	Written Request- Amendment 2 [PDF -62KB]
Temsirolimus	Pfizer	2/28/2012	Written Request [PDF -204KB] [*note for vision impaired users] Amendment 1 [PDF -135KB] Amendment 2 [PDF -192KB] Amendment 3 [PDF -35KB] Amendment 4 [PDF -84KB] Amendment 5 [PDF -80KB]
Tenofovir	Gilead Sciences, Inc.	9/6/2011	Written Request [PDF -57KB] Amendment 1 [PDF -32KB] Amendment 2 [PDF -50KB] Amendment 3 [PDF -73KB] Amendment 4 [PDF -111KB] Amendment 5 [PDF -72KB]
Tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	3/7/2008	Written Request [PDF -95KB]
Topiramate	Ortho-McNeil-Janssen Pharmaceuticals, Inc.	7/24/2008	Written Request [PDF -280KB] Amendment 1 [PDF -184KB]
Valacyclovir	GlaxoSmithKline	2/28/2008	Written Request [PDF -160KB] Amendment 1 [PDF -167KB]
Valganciclovir	Hoffman-La Roche Inc.	7/24/2008	Written Request [PDF -266KB] Amendment 1 [PDF -333KB] Amendment 2 [PDF -200KB] Amendment 3 [PDF -342KB] Amendment 4 [PDF -514KB]
Valproate	Abbott	12/14/2007	Written Request [PDF -69KB]
Zoledronic acid	Novartis	12/21/2007	Written Request [PDF -291KB]