Consumer Product Safety Improvement Act.

The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires manufacturers and importers of certain consumer products (including certain drug products) manufactured on or after November 12, 2008, to certify that their products comply with all applicable rules, bans, standards, or regulations enforced by the Consumer Product Safety Commission (CPSC). Under the CPSIA, manufacturers and importers must make available to customers a certificate specifying that the product complies with the applicable CPSC rule, ban, standard, or regulation. Such certification must be based on a test of each product or upon a reasonable testing program.

Sensipar® (cinacalcet)

Sensipar® is sold in special child-resistant packaging that must meet the requirements of the Poison Prevention Packaging Act. Accordingly, Amgen furnishes below links to the General Conformity Certificates for the product identified by corresponding finished drug product batch number.

2010 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1017759 1017831 1018705
1021557 1021559 1022667
1022668 1022669 1023614
1023631

60 mg.
1017761 1019516 1021561
1023616

90 mg.
1021563 1023613

2011 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1024178
1025473
1026589
1028910
1030582
1031846
1025043
1026087
1027209
1029483
1031125
1032623
1025471
1026580
1028911
1030035
1031438
 

60 mg.
1024179
1025472
1027211
1031126
1024180
1026088
1028912
1031148
1025044
1026584
1029484
1031435

90 mg.
1025045
1028913
1033202
1025474
1029486
1034102
1026587
1030583
 

2012 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1029560
1034908
1034109
1035453
1039163
1032819
1035449
1034809
1037965
1039162
1034107
1033475
1035450
1039164
 

60 mg.
1029561 1029562 1033165
1034829 1033474 1036048
1035294 1038074 1038599
1038600 1039165  

90 mg.
1029563 1034666 1037588
1038596 1038219 1039166
1038597 1040453  

2013 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1039737 1039738 1040672
1040673 1040674 1041276
1041277 1041897 1041898
1042484 1042485 1043234
1043805 1044711 1044712
1044713    

60 mg.
1039739 1040675 1040676
1041278 1041279 1041899
1042486 1042487 1042601
1043235 1043236 1043806

90 mg.
1040540 1041280 1041900
1043807 1044714 1045557

2014 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1042667 1045566 1046409
1046410 1047135 1047137
1048082 1048083 1048618
1049003 1050036 1050037
1050038 1050983 1050984
1050985 1051383 1051634
1051636 1051637 1051641
1053210 1053211 1053974
1053975 1054046 1055069
1055070    

60 mg.
1046408 1047133 1048084
1049001 1049002 1050039
1050982 1051638 1051639
1051640 1052161 1052162
1053212 1053499 1053977
1055072    

90 mg.
1047134 1048086 1050040
1050986 1052163 1052164
1053213 1053217 1053976
1055073    

2015 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1057502 1059713 1060192
1060362 1060365 1061214
1061215 1062098 1062099
1062750 1062749 1063823
1063824 1065502 1065503
1066084 1066660 1065504
1064605    

60 mg.
1059714 1060363 1061216
1063820 1062097 1062308
1064608 1064607 1064609
1065501 1063821 1066085
1066659    

90 mg.
1059715 1060364 1062100
1062820 1062821 1063041
1063822 1064966 1065211

2016 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
1064606 1065874 1067557
1067929 1067930 1067932
1069089 1069095 1070111
1070112 1070113 1071491
1071492 1069555 1072641
1073444 1073445 1073447
1074454 1074687 1075745
1076476 1077151

60 mg.
1066658 1067780 1067781
1069088 1070115 1071493
1071494 1073446 1073448
1073449 1073450 1074829
1075610

90 mg.
1067782 1068931 1069084
1071495 1071551 1070116
1073451

For questions, please call Amgen Medical Information at 1-800-77AMGEN (1-800-772-6436).