| Name |
Application |
Date REMS Approved |
REMS Components
All REMS include timetable for assessment |
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)  |
NDA 21-077/S-029 |
4/30/2008 |
medication guide |
| Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) |
NDA 21-254/S-004 |
7/31/2008 |
medication guide |
| Aplenzin (buproprion hydrobromide) Extended-Release Tablets |
NDA 22-108 |
4/23/2008 |
medication guide |
Avandamet (rosiglitazone maleate
and metformin
hydrochloride) Tablets |
NDA 21-410/S-025 |
12/2/2008 |
medication guide |
| Avandaryl (rosiglitazone maleate and glimepiride) Tablets |
NDA 21-700/S-008 |
12/2/2008 |
medication guide |
| Banzel (rufinamide) Tablets |
NDA 21-911 |
11/14/2008 |
medication guide |
| Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection |
BLA 125160/0 |
modified 12/31/2008 |
medication guide, communication plan |
| Creon (pancrelipase) Delayed-Release Capsules |
NDA 20-725 |
4/30/2009 |
medication guide |
Edluar (zolpidem tartrate)
Sublingual Tablets |
NDA 21-997 |
3/13/2009 |
medication guide |
| Enbrel (etanercept) for Subcutaneous Injection |
BLA 103795/5359 |
6/23/2008 |
medication guide |
| Entereg (alvimopan) Capsules |
NDA 21-775 |
modified 2/5/2009 |
communication plan, elements to assure safe use, implementation system |
| Epzicom (abacavir sulfate and lamivudine) Tablets |
NDA 21-652/S-008 |
3/9/2009 |
medication guide |
| Intron A (interferon alfa-2a) |
BLA 103132/5108 |
5/2/2008 |
medication guide |
| Kaletra (lopinavir and ritonavir) Oral Solution |
NDA 21-906/S-014, 21-251/S-023 |
4/6/2009 |
medication guide |
Nplate (romiplostim) for
Subcutaneous Injection |
BLA 125268 |
8/22/2008 |
medication guide, communication plan,
elements to assure safe use, implementation system |
| Pegasys (peginterferon alfa-2a) |
BLA 103964/5133 |
10/31/2008 |
medication guide |
PegIntron (peginterferon
alfa-2b) |
BLA 103949/5171, 5174 |
12/11/2008 |
medication guide |
PegIntron Rebetol Combopack
(Peginterferon alfa-2b, Redipen
Single-dose Delivery System
and Rebetol Ribavirin) |
BLA 125196/0 |
6/13/2008 |
medication guide |
| Promacta (eltrombopag) Tablets |
NDA 22-291 |
11/20/2008 |
medication guide, elements to assure safe use, implementation system |
| Rozarem (ramelteon) Tablets |
NDA 21-782/S-008, S-009, S-010 |
10/20/2008 |
medication guide |
Savella (milnacipran
hydrochloride)
Tablets |
NDA 22-256 |
1/14/2009 |
medication guide |
| Sucraid (sacrosidase) Oral Solution |
NDA 20-772/S-005 |
11/20/2008 |
communication plan, elements to assure safe use, implementation system |
| Symbicort (budesonide and formoterol) Inhalation Aerosol) |
NDA 21-929/S-012 |
2/27/2009 |
medication gude |
| Symbyax (olanzapine and fluoxetine) Capsules |
NDA 21-520/S-012 |
3/19/2009 |
medication guide |
| Tapentadol Tablets |
NDA 22-304 |
11/20/2008 |
medication guide |
| Treximet (sumatriptan succinate and naproxen sodium) Tablets |
NDA 21-926 |
4/15/2008 |
medication guide |
| Trilipix (fenofibric acid) Delayed-Release Capsules |
NDA 22-224 |
12/15/2008 |
medication guide |
| Trizivir (abacavir sulfate, lamivudine, and zidovudine) |
NDA 21-205/S-021 |
3/9/2009 |
medication guide |
| Tyzeka (telbivudine) Tablets |
NDA 22-011/S-001 |
1/23/2009 |
medication guide |
| Venlafaxine hydrochloride Extended- Release Tablets |
NDA 22-104 |
5/20/2008 |
medication guide |
| Vimpat (lacosamide) Injection |
NDA 22-253, 22-254 |
10/28/2008 |
medication guide |
| Viramune (nevirapine) Tablets and Oral Suspension |
NDA 20-636/S-027; 20-933/S-017 |
6/24/2008 |
medication guide |
| Xenazine (tetrabenazine) Tablets |
NDA 21-894 |
8/15/2008 |
medication guide, communication plan |
| Ziagen (abacavir sulfate) Tablets and Oral Solution |
NDA 20-977/S-017, 20-978/S-020 |
7/18/2008 |
medication guide |
Zolpimist (zolpidem tartrate)
Oral Spray |
NDA 22-196 |
12/19/2008 |
medication guide |
| Zyprexa, Zyprexa Zydis (olanzapine) Tablets |
NDA 20-592/S-039, 21-086/S-021 |
3/19/2009 |
medication guide |
