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).

Find the Pediatric Exclusivity Determinations in the FDA Archive

 

N=174

Drug	Sponsor	Determination Date	Written Request and Related Documents
Abacavir/ dolutegravir/ lamivudine	ViiV Healthcare Company	6/7/2023	Written Request [PDF - 465 KB] Amendment 1 [PDF - 201KB] Amendment 2 [PDF - 523 KB]
Abatacept	BMS	2/14/2017	Written Request [PDF - 54KB] Amendment 1 [PDF - 78KB]
Acetaminophen	Mallinckrodt	7/11/2016	Written Request [PDF -157KB] Amendment 1 [PDF -168KB] Amendment 2 [PDF -160KB] Amendment 3 [PDF -240KB]
Afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	3/8/2022	Written Request [PDF -150 KB] Amendment 1 [PDF - 118 KB] Amendment 2 [PDF - 153 KB] Amendment 3 [PDF - 376 KB] Amendment 4 [PDF - 326 KB]
Aflibercept	Regeneron Pharmaceuticals	10/18/2022	Written Request [PDF -150 KB]
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]
Aliskiren	Noden Pharma DAC	10/3/2017	Written Request [PDF - 54 KB] Amendment 1 [PDF - 47 KB] Amendment 2 [PDF - 24 KB] Amendment 3 [PDF - 215 KB]
Almotriptan	Johnson & Johnson Pharmaceutical Research & Development	1/13/2009	Written Request [PDF -197KB] Reissue [PDF -102KB]
Amphetamine	Shire	8/18/2019	Written Request [PDF -157 KB] Amendment 1 [PDF -168 KB] Amendment 2 [PDF -160 KB]
Anastrozole	AstraZeneca	11/14/2007	Written Request - Amendment 4 [PDF - 416KB]
Apremilast	Amgen Inc.	4/22/2024	Written Request [PDF - 146 KB] Amendment 1 [PDF - 168 KB] Amendment 2 [PDF - 232KB]
Aripiprazole	Otsuka	11/14/2007	Written Request [PDF -499KB]
Asenapine	Forest Labs	3/3/2015	Written Request [PDF - 704KB] Amendment 1 [PDF - 214KB] Amendment 2 [PDF - 209KB] Amendment 3 [PDF - 98KB] Amendment 4 [PDF - 230KB]
Atazanavir	BMS	6/23/2015	Written Request [PDF -100KB] Amendment 1 [PDF -280KB] Reissue Amendment 1 [PDF -89KB] Reissue Amendment 2 [PDF -122KB] Reissue Amendment 3 [PDF -121KB] Reissue Amendment 4 [PDF -134KB] Reissue Amendment 5 [PDF -114KB] Reissue Amendment 6 [PDF -114KB]
Atezolizumab	Genentech	9/22/2020	Written Request [PDF - 263 KB] Amendment 1 [PDF - 329 KB]
Axitinib	Pfizer, Inc.	7/2/2024	Written Request [PDF - 830 KB] Amendment 1 [PDF - 1.06 MB] Amendment 2 [PDF - 1,014 KB] Amendment 3 [PDF - 282 KB]
Azelastine/Fluticasone and Azelastine	Meda Pharmaceuticals	3/23/2015	Written Request [PDF -122KB]
Bendamustine	Cephalon	5/24/2012	Written Request [PDF -116KB] Amendment 1 [PDF -159KB] Amendment 2 [PDF -113KB]
Bezlotoxumab	Merck Sharpe and Dohme	5/12/2023	Written Request [PDF - 718 KB] Amendment 1 [PDF - 314 B]
Bicalutamide	AstraZeneca	9/19/2008	Written Request [PDF -256KB] Amendment 1 [PDF -264KB] Amendment 3 [PDF -236KB] Amendment 4 [PDF -185KB] Amendment 5 [PDF -297KB] Amendment 6 [PDF -182KB]
Bivalirudin	The Medicines Company	6/17/2009	Written Request [PDF -504KB]
Blinatumomab	Amgen	6/13/2023	Written Request [PDF - 256 KB] Amendment 1 [PDF - 264 KB] Amendment 2 [PDF - 236 KB] Amendment 3 [PDF - 185 KB]
Bosutinib	PF Prism, C.V.	9/7/ 2023	Written Request [PDF - 256 KB] Amendment 1 [PDF - 264 KB] Amendment 2 [PDF - 236 KB] Amendment 3 [PDF - 185 KB] Amendment 4 [PDF - 185 KB]
Bortezomib	Millennium Pharmaceuticals	8/14/2015	Written Request [PDF -116KB] Amendment 1 [PDF -159KB] Amendment 2 [PDF -113KB]
Brentuximab vedotin	Seagen, Inc.	11/18/2022	Written Request [PDF -116 KB] Amendment 1 [PDF -159 KB]
Brexpiprazole	Otsuka Pharmaceutical Development & Commercialization	5/2/2024	Written Request [PDF -821 KB] Amendment 1 [PDF - 82 KB] Amendment 2 [PDF -152 KB] Amendment 3 [PDF -156 KB] Amendment 4 [PDF -303 KB]
Budesonide/Formoterol	AstraZeneca	1/25/2017	Written Request [PDF - 181KB] Amendment 1 [PDF - 178KB] Amendment 2 [PDF - 195KB] Amendment 3 [PDF - 172KB] Amendment 4 [PDF - 276KB]
Cabazitaxel	Sanofi Aventis	5/18/2017	Written Request [PDF - 91 KB] Amendment 1 [PDF - 2345 KB] Amendment 2 [PDF -  250 KB]
Calcipotriene/Betamethasone	Leo Pharma	7/15/2019	Written Request [PDF - 109 KB]
Canagliflozin	Janssen Pharmaceuticals, Inc.	12/9/2024	Written Request [PDF - 157 KB] Amendment 1 [PDF - 149 KB] Amendment 2 [PDF - 169 KB] Amendment 3 [PDF - 205 KB] Amendment 4 [PDF - 194 KB] Amendment 5 [PDF - 135 KB] Amendment 6 [PDF - 138 KB]
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]
Capecitabine	Hoffman-La Roche, Inc.	8/28/2013	Written Request [PDF -319KB] Amendment 1 [PDF -96KB] Amendment 2 [PDF -136KB] Amendment 3 [PDF -156KB]
Caspofungin	Merck & Co., Inc.	4/15/2008	Written Request - Amendment 4 [PDF -91KB]
Cetirizine	Nicox Ophthalmics	8/29/16	Written Request [PDF -136KB] Written Request - Amendment 1 [PDF -171KB]
Clopidogrel	Sanofi Aventis	1/20/2011	Written Request [PDF -172KB] Amendment 1 [PDF -116KB]
Cobimetinib	Genentech, Inc.	7/19/2022	Written Request [PDF -139 KB] Written Request 2 [PDF - 61 KB] Amendment 1 [PDF -159 KB]
Colesevelam	Daiichi Sankyo Pharma	2/17/2009	Written Request [PDF -208KB] Amendment 1 [PDF -112KB] Amendment 2 [PDF -69KB] Amendment 3 [PDF -115KB]
Crisaborole	Pfizer	2/21/2020	Written Request [PDF - 45 KB]  Amendment 1 [PDF - 71 KB]
Cysteamine	Horizon	12/12/2017	Written Request [PDF - 45 KB]  Amendment 1 [PDF - 71 KB]
Dabigatran	Boehringer Ingelheim Pharmaceuticals, Inc.	2/12/2021	Written Request [PDF - 41 KB]  Amendment 1 [PDF - 160 KB]
Dabrafenib	Novartis	2/9/2023	Written Request [PDF - 275 KB] Amendment 1 [PDF - 208 KB] Amendment 2 [PDF - 414 KB] Amendment 3 [PDF - 286 KB] Amendment 4 [PDF - 654 KB] Amendment 5 [PDF - 677 KB]
Dapagliflozin	AstraZeneca AB	5/30/2024	Written Request [PDF - 742 KB] Written Request Reissue [PDF - 69 KB] Amendment 1 [PDF - 141 KB] Amendment 2 [PDF - 104 KB] Amendment 3 [PDF - 95 KB]
Darunavir	Tibotec	6/7/2011	Written Request [PDF -101KB] Amendment 1 [PDF -102KB]
Deutetrabenazine	Teva Branded Pharmaceutical Products	5/5/2021	Written Request [PDF - 158 KB] /
Dexmedetomidine	Hospira	3/12/2013	Written Request [PDF -146KB] Amendment 1 [PDF -150KB] Amendment 2 [PDF -266KB]
Difluprednate	Alcon	3/21/2013	Written Request [PDF -79KB] Amendment 1 [PDF -42KB]
Docetaxel	Sanofi Aventis	3/17/2010	Written Request [PDF -126KB]
Dulaglutide	Eli Lilly and Company	October 4, 2022	Written Request [PDF -151 KB] Amendment 1 [PDF - 158 KB] Amendment 2 [PDF - 82 KB] Amendment 3 [PDF - 132 KB]
Duloxetine	Eli Lilly	7/2/2012	Written Request [PDF -76KB] Amendment 1 [PDF -151KB] Amendment 2 [PDF -145KB]
Efavirenz	BMS	1/29/2013	Written Request [PDF -122KB] Amendment 1 [PDF -79KB] Amendment 2 [PDF -136KB] Amendment 3 [PDF -130KB] Amendment 4 [PDF -151KB] Amendment 5 [PDF -92KB] Amendment 6 [PDF -67KB] Amendment 7 [PDF -116KB]
Eltrombopag	Novartis	8/14/2015	Written Request [PDF -699KB] Amendment 1 [PDF -212KB]
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide	Gilead Sciences, Incorporated	9/13/2021	Written Request [PDF - 63 KB] Amendment 1 [PDF - 248 KB]
Empagliflozin/Empagliflozin and Metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals	6/9/2023	Written Request [PDF - 48 KB] Amendment 1 [PDF - 48 KB] Amendment 2 [PDF - 104 KB]
Entecavir	BMS	12/5/2013	Written Request [PDF -112KB] Amendment 1 [PDF -133KB] Amendment 2 [PDF -135KB] Amendment 3 [PDF -241KB]
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]
Eribulin Mesylate	Eisai, Inc.	8/9/2022	Written Request [PDF - 164 KB] Amendment 1 [PDF - 184 KB] Amendment 2 [PDF - 198 KB] Amendment 3 [PDF - 230 KB]
Erlotinib	OSI Pharmaceuticals	3/18/2015	Written Request [PDF -154 KB] Amendment 1 [PDF -157 KB]
Esomeprazole	AstraZeneca LP	5/1/2009	Written Request [PDF -243 KB] Amendment 1 [PDF -235 KB] Amendment 2 [PDF -235 KB] Amendment 3 [PDF -242 KB] Amendment 4 [PDF -249 KB]
Eszopiclone	Sunovion	6/29/2012	Written Request [PDF -217KB] Amendment 1 [PDF -245KB]
Etravirine	Janssen	6/21/2018	Written Request [PDF - 40 KB] Amendment 1 [PDF - 36 KB] Amendment 2 [PDF - 50 KB] Amendment 3 [PDF - 50 KB] Amendment 4 [PDF - 146 KB]
Everolimus	Novartis	7/10/2012	Written Request [PDF -145KB]
Exenatide	AstraZeneca	4/1/2021	Written Request [PDF - 103 KB] Amendment 1 [PDF - 95 KB] Amendment 2 [PDF - 106 KB] Amendment 3 [PDF -127 KB] Amendment 4 [PDF -125 KB] Amendment 5 [PDF -103 KB] Amendment 6 [PDF -103 KB] Amendment 7 [PDF -566 KB] Amendment 8 [PDF - 530 KB]
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]
Fenfluramine hydrochloride	Zogenix, Inc	3/23/2022	Written Request [PDF - 112 KB] Amendment 1 [PDF -45 KB]
Ferric Oxyhydroxide	Vifor Fresenius Medical Care Renal Pharma France	6/1/2021	Written Request [PDF - 206 KB] Amendment 1 [PDF - 177 KB] Written Request Reissue [PDF - 186 KB]
Fesoterodine	Pfizer	6/3/2021	Written Request [PDF - 185 KB] Amendment 1 [PDF - 349 KB] Amendment 2 [PDF - 225 KB] Amendment 3 [PDF - 231 KB]
Fidaxomicin	Cubist	12/13/2019	Written Request [PDF - 399 KB]
Finafloxacin	Alcon	8/25/2014	Written Request [PDF -66KB]
Fingolimod	Novartis	4/16/2018	Written Request [PDF - 34 KB] Amendment 1 [PDF - 71 KB]
Fluticasone & Fluticasone/Salmeterol	Teva Pharmaceutical Industries Ltd.	6/10/2021	Written Request [PDF -155 KB] Amendment 1 [PDF - 684 KB] Amendment 2 [PDF - 632 KB]
Fluticasone furoate vilanterol trifenatate	GlaxoSmithKline	4/26/2023	Written Request [PDF -137 KB] Amendment 1 [PDF - 684 KB] Amendment 2 [PDF - 632 KB]
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]
Fosaprepitant	Merck	3/23/2018	Written Request [PDF - 80 KB] Amendment 1 [PDF - 139 KB] Amendment 2 [PDF - 85 KB] Amendment 3 [PDF - 57 KB] Amendment 4 [PDF - 109KB]
Fulvestrant	AstraZeneca	2/1/2011	Written Request [PDF -62 KB] Amendment 1 [PDF -63 KB]
Gatifloxacin	Allergan	5/19/2009	Written Request [PDF -1 50 KB] Amendment 1 [PDF - 63KB]
Glecaprevir/Pibrentasvir	AbbVie, Inc.	5/18/2021	Written Request [PDF - 62 KB] Amendment 1 [PDF - 63 KB] Amendment 2 [PDF - 63 KB]
Guanfacine	Shire	10/17/2014	Written Request [PDF -150KB]
Halobetasol	Mayne Pharma LLC	5/21/2021	Written Request [PDF - 180 KB] Amendment 1 [PDF - 396 KB]
Ibrutinib	Pharmacyclics	8/8/2022	Written Request [PDF - 152 KB] Amendment 1 [PDF - 108 KB] Amendment 2 [PDF - 179 KB]
Ipilimumab	BMS	7/20/17	Written Request [PDF - 253 KB] Amendment 1 [PDF - 194 KB]
Isavuconazonium sulfate	Astellas Pharma US Inc.	11/29/2023	Written Request [PDF - 152 KB] Amendment 1 [PDF - 328 KB]
Ixabepilone	BMS	4/5/2011	Written Request [PDF -69KB] Amendment 1 [PDF - 91KB] Amendment 2 [PDF - 135KB]
Ivabradine	Amgen	3/30/2019	Written Request [PDF - 1 MB] Amendment 1 [PDF - 109 KB]
Lanadelumab	Takeda Pharmaceuticals U.S.A., Inc.	12/20/2022	Written Request [PDF - 102 KB] Amendment 1 [PDF - 145 KB
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]
Lenvatinib Mesylate	Eisai Inc.	4/1/2024	Written Request [PDF - 845 KB] Amendment 1 [PDF - 700 KB] Amendment 2 [PDF - 378 KB]
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]
Linagliptin/Linagliptin and metformin hydrochloride	Boehringer Ingelheim Pharmaceuticals	6/9/2023	Written Request [PDF - 351 KB] Written Request Reissued [PDF - 161 KB] Amendment 1 [PDF - 161 KB]
Liraglutide	Novo Nordisk	5/1/2019	Written Request [PDF - 335 KB] Amendment 1 [PDF - 276 KB] Amendment 2 [PDF - 144 KB]
Lisdexamfetamine	Takeda Pharmaceuticals USA, Inc.	7/27/2021	Written Request [PDF - 197 KB]
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]
Lumacaftor/Ivacaftor NEW	Vertex Pharmaceuticals Inc.	12/11/2024	Written Request [PDF - 86KB]
Lurasidone	Sunovion	12/20/2016	Written Request [PDF - 241KB]
Lutetium Lu 177 dotatate	Advanced Accelerator Applications	4/19/2024	Written Request [PDF - 789 KB] Reissue 1 [PDF - 121 KB] Amendment 1 [PDF - 535 KB] Amendment 2 [PDF - 975 KB]
Maraviroc	ViiV Healthcare Co	7/29/2020	Written Request [PDF - 94 KB] Amendment 1 [PDF - 134 KB] Amendment 2 [PDF - 220 KB] Amendment 3 [PDF - 219 KB]
Memantine	Forest Labs	6/16/2014	Written Request [PDF - 200KB] Amendment 1 [PDF - 266KB]
Methylphenidate	Rhodes Pharmaceuticals	3/15/2019	Written Request [PDF - 35KB] Amendment 1 [PDF - 595 KB]
Micafungin	Astellas	11/14/2019	Written Request [PDF - 94 KB] Amendment 1 [PDF - 91 KB] Amendment 2 [PDF - 90 KB] Amendment 3 [PDF - 89 KB] Amendment 4 [PDF - 82 KB] Written Request Reissue [PDF - 130 KB]
Mirabegron	Astellas Pharma Global Development, Inc.	3/1/2021	Written Request [PDF - 154 KB]
Mometasone/formoterol	Merck	6/24/2019	Written Request [PDF - 71 KB]
Nilotinib	Novartis	3/20/2018	Written Request [PDF - 35 KB] Amendment 1 [PDF - 595 KB] Amendment 2 [PDF - 456 KB] Amendment 3 [PDF - 490 KB]
Nintedanib	Boehringer Ingelheim Pharmaceuticals	10/6/2023	Written Request [PDF - 146 KB] Amendment 1 [PDF - 161 KB]
Nitric Oxide	INO Therapeutics	11/2/2010	Written Request [PDF -117 KB]
Nivolumab		2/2/2023	Written Request [PDF - 176 KB] Amendment 1 [PDF - 41 KB] Amendment 2 [PDF - 366 KB] Amendment 3 [PDF - 424 KB]
Olmesartan	Daiichi Sankyo	10/7/2009	Written Request [PDF - 29 KB] Amendment 1 [PDF -271 KB] Reissue [PDF -130 KB]
Olopatadine	Alcon Research, Ltd.	8/12/2009	Written Request [PDF -49KB]
Olopatadine	Alcon Research, Ltd.	12/16/2014	Written Request [PDF -100KB]
Paclitaxel	Abraxis	11/8/2019	Written Request [PDF - 247 KB] Amendment 1 [PDF - 182 KB] Amendment 2 [PDF - 139 KB] Amendment 3 [PDF - 228 KB]
Paliperidone	Ortho-McNeil-Janssen Pharmaceuticals, Inc.	1/5/2011	Written Request [PDF -72 KB] Amendment 1 [PDF -40 KB] Amendment 2 [PDF -103 KB]
Palonosetron	Helsinn	4/10/2014	Written Request [PDF -247 KB] Amendment 1 [PDF -182 KB] Amendment 2 [PDF -139 KB] Amendment 3 [PDF -228 KB]
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]
Phenylephrine/Ketorolac	Omeros	12/6/2017	Written Request [PDF - 309 KB]
Pitavastatin	Kowa Research Institute]	3/30/2019	Written Request [PDF - 157 KB] Amendment 1 [PDF - 147 KB
Pomalidomide	Celgene Corporation	10/16/2020	Written Request [PDF - 158 KB] Amendment 1 [PDF - 174 KB] Amendment 2 [PDF - 65 KB
Prasugrel	Eli Lilly	5/23/16	Written Request [PDF -247KB] Amendment 1 [PDF -182KB] Amendment 2 [PDF -139KB]
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]
Raltegravir	Merck	8/14/2017	Written Request [PDF - 38 KB] Amendment 1 [PDF - 22 KB] Amendment 2 [PDF - 53 KB] Amendment 3 [PDF - 139KB] Amendment 4 [PDF - 151 KB]
Remdesivir	Gilead Sciences, Inc.	January 23, 2024	Written Request [PDF - 172 KB] Amendment 1 [PDF - 22 KB]
Rilpivirine	Janssen Products, LP.	1/18/2024	Written Request [PDF - 122 KB] Amendment 1 [PDF - 69 KB] Amendment 2 [PDF - 56 KB] Amendment 3 [PDF - 56 KB] Amendment 4 [PDF - 112 KB] Amendment 5 [PDF - 89 KB] Reissue [PDF - 103 KB] Reissue Amendment 1 [PDF - 1,034 KB] Reissue Amendment 2 [PDF - 406 KB]
Risedronate	Procter & Gamble Pharmaceuticals, Inc.	4/24/2009	Written Request [PDF -186KB] Amendment 1 [PDF -173KB] Amendment 2 [PDF -190KB]
Rivaroxaban	Janssen Pharmaceuticals, Inc.	11/23/2021	Written Request [PDF -186 KB] Amendment 1 [PDF -173 KB]
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]
Rufinamide	Eisai	1/13/2015	Written Request [PDF -168KB]  Amendment [PDF -239KB]
Ruxolitinib	Incyte Corporation	12/1/2022	Written Request [PDF - 257 KB]  Amendment 1 [PDF - 264 KB] Amendment 2 [PDF - 613 KB]
Sacubitril/Valsartan	Novartis	9/26/2019	Written Request [PDF - 168KB]  Amendment [PDF - 239KB]
Sapropterin	BioMarin	3/13/2014	Written Request [PDF -121KB]  Amendment [PDF -176KB]
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]
Sitagliptin	Merck Sharp & Dohme Corp.	10/30/2020	Written Request [PDF - 245 KB] Amendment 1 [PDF - 145 KB] Amendment 2 [PDF - 92 KB]
Sofosbuvir	Gilead Sciences, Inc.	7/23/2019	Written Request [PDF - 157 KB] Amendment 1 [PDF - 380 KB] Amendment 2 [PDF - 253 KB] Amendment 3 [PDF - 253 KB]
Sofosbuvir/Ledipasvir	Gilead Sciences, Inc.	7/23/2019	Written Request [PDF - 262 KB] Amendment 1 [PDF - 262 KB] Amendment 2 [PDF - 399 KB] Amendment 3 [PDF - 157 KB]
Sofosbuvir/Velpatasvir	Gilead Sciences, Inc.	5/13/2021	Written Request [PDF - 165 KB] Amendment 1 [PDF - 95 KB] Amendment 2 [PDF - 93 KB]
Solifenacin	Astellas	7/20/2017	Written Request [PDF - 49 KB] Amendment 1 [PDF - 54 KB] Amendment 2 [PDF - 117 KB] Amendment 3 [PDF - 110 KB]
Sugammadex	Merck, Sharp & Dohme LLC (Merck)	12/9/2024	Written Request [PDF - 102 KB] Amendment 1 [PDF - 693 KB] Amendment 2 [PDF - 826 KB] Amendment 3 [PDF - 494 KB] Amendment 4 [PDF - 548 KB] Amendment 5 [PDF - 426 KB]
Sumatriptan/Naproxen	GlaxoSmithKline/Pernix	4/16/2015	Written Request [PDF -133KB]
Tadalafil	Eli Lilly	11/16/2017	Written Request (PDF - 164KB) Amendment 1 (PDF -  59KB) Amendment 2 (PDF -  171KB) Amendment 3 (PDF - 223KB)
Tamsulosin	Boehringer Ingelheim	9/17/2009	Amendment 1 [PDF -50KB] Amendment 2 [PDF -68KB] Amendment 3 [PDF -80KB]
Tapentadol	Collegium Pharmaceutical Inc.	June 11, 2024	Written Request [PDF - 1.4 MB] Amendment 1 [PDF - 184 KB] Amendment 2 [PDF - 833 KB] Amendment 3 [PDF - 763 KB] Amendment 4 [PDF - 89 KB] Amendment 5 [PDF - 311 KB]
Tavaborole	Anacor	7/18/2018	Written Request (PDF - 106 KB) Amendment 1 (PDF -  115 KB)
Tbo-filgrastim	Sicor	7/18/2018	Written Request (PDF - 204 KB) Amendment 1 (PDF -  242 KB)
Technetium Tc99 sestamibi	BMS	1/11/2008	Written Request- Amendment 2 [PDF -62KB]
Teduglutide	Shire - NPS Pharmaceuticals	3/7/2019	Written Request [PDF - 243 KB] Amendment 1 [PDF - 251 KB] Amendment 2 [PDF - 184 KB]
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]
Tenofovir	Gilead Sciences, Inc.	11/15/2018	Written Request [PDF - 173 KB] Amendment 1 [PDF -  263 KB] Amendment 2 [PDF - 43 KB]
Teriflunomide	Sanofi Aventis	3/31/2021	Written Request [PDF - 76 KB] Written Request Reissued [PDF - 84 KB]
Ticagrelor	AstraZeneca	4/8/2022	Written Request [PDF - 182 KB] Amendment 1 [PDF - 789 KB]
Tiotropium	Boehringer Ingelheim Pharmaceuticals, Inc.	12/14/16	Written Request [PDF - 128KB]
Tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	3/7/2008	Written Request [PDF -95KB]
Tocilizumab	Genentech/Hoffmann-La Roche	7/18/2018	Written Request [PDF -240 KB] Amendment 1 [PDF -292 KB]
Topiramate	Ortho-McNeil-Janssen Pharmaceuticals, Inc.	7/24/2008	Written Request [PDF -280KB] Amendment 1 [PDF -184KB]
Trabectedin	Janssen	6/12/2018	Written Request [PDF - 132 KB]
Trametinib	Novartis	2/9/2023	Written Request [PDF - 257 KB] Amendment 1 [PDF - 469 KB] Amendment 2 [PDF - 613 KB] Amendment 3 [PDF - 513 KB]
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 -333 KB] Amendment 2 [PDF -200 KB] Amendment 3 [PDF -342 KB] Amendment 4 [PDF -514 KB]
Valproate	Abbott	12/14/2007	Written Request [PDF - 69 KB]
Varenicline	Pfizer	11/15/2018	Written Request [PDF - 266 KB] Amendment 1 [PDF - 333 KB] Amendment 2 [PDF - 200 KB] Amendment 3 [PDF - 342 KB]
Vigabatrin	Lundbeck	10/3/2013	Written Request [PDF -176 KB] Amendment 1 [PDF - 366 KB]
Vilazodone	Allergan	1/21/2020	Written Request [PDF -176KB] Amendment 1 [PDF - 366KB]
Vortioxetine	Takeda Pharmaceuticals USA Inc.	8/21/2023	Written Request [PDF - 155 KB] Amendment 1 [PDF - 304 KB] Amendment 2 [PDF - 158 KB]
Zoledronic acid	Novartis	12/21/2007	Written Request [PDF -291 KB]

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