atin, titanium dioxide, FD&C blue 2, yellow iron oxide and white ink.
The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2 and white ink.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued February 2013
Manufactured for:
Celgene Corporation
Summit, NJ 07901
Pomalyst®, REVLIMID®and THALOMID® are registered trademarks of Celgene Corporation.
Pomalyst REMS™ is a trademark of Celgene Corporation.
U.S. Pat. Nos. 5,635,517; 6,045,501; 6,315,720; 6,316,471; 6,476,052; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 8,158,653; 8,198,262; 8,204,763; 8,315,886.
©2005-2013 Celgene Corporation, All Rights Reserved.
POMMG.001 02/13
Pomalyst® (pomalidomide) Capsules, 1 mg - 21 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 1 mg - 100 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 2 mg - 21 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 2 mg - 100 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 3 mg - 21 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 3 mg - 100 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 4 mg - 21 Count Bottle Label
Pomalyst® (pomalidomide) Capsules, 4 mg - 100 Count Bottle Label
Pomalyst
pomalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59572-501
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POMALIDOMIDE (POMALIDOMIDE) POMALIDOMIDE 1.00 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 53.68 mg
STARCH, CORN 70.00 mg
SODIUM STEARYL FUMARATE 0.32 mg
Product Characteristics
Color YELLOW, BLUE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code POML;1;mg
Contains
Packaging
Item Code Package Description
1 NDC:59572-501-21 21 CAPSULE in 1 BOTTLE
2 NDC:59572-501-00 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204026 02/18/2013
Pomalyst
pomalidomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59572-502
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POMALIDOMIDE (POMALIDOMIDE) POMALIDOMIDE 2.00 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 107.36 mg
STARCH, CORN 140.00 mg
SODIUM STEARYL FUMARATE 0.64 mg
Product Characteristics
Color ORANGE, BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code POML;2;mg
Contains
Packaging
Item Code Package Description
1 NDC:59572-502-21 21 CAPSULE in 1 BOTTLE
2 NDC:59572-502-00 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204026 02/18/2013
Pomalyst
pomalidomide capsule
Product Information
Product T
