| 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 |
| Aplezin (buproprion hydrobromide) Extended-Release Tablets |
NDA 22-108 |
4/23/2008 |
medication guide |
| Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection |
BLA 125160/0 |
4/22/2008 |
medication guide, elements to assure safe use |
| Enbrel (etanercept) for Subcutaneous Injection |
BLA 103795/5359 |
6/23/2008 |
medication guide |
| Entereg (alvimopan) Capsules |
NDA 21-775 |
5/20/2008 |
communication plan, elements to assure safe use |
| Intron A (interferon alfa-2a) |
BLA 103132/5108 |
5/2/2008 |
medication guide |
| PegIntron Rebetrol Combopack (Peginterferon alfa-2b, Redipen Single-dose Delivery System and Rebetol Ribavirin) |
BLA 125196/0 |
6/13/2008 |
medication guide |
Nplate (romiplostim) for
Subcutaneous Injection |
BLA 125268 |
8/22/2008 |
medication guide, communication plan, elements to assure safe use, implementation system |
| Treximet (sumatriptan succinate and naproxen sodium) Tablets |
NDA 21-926 |
4/15/2008 |
medication guide |
| Venlafaxine hydrochloride extended release tablets |
NDA 22-104 |
5/20/2008 |
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 |
