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.

Otezla® (apremilast)

Otezla®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.

2019 General Conformity Certificates identified by corresponding finished drug product batch number.

30 mg.
F2598BA F2598BB F2585A F2586A F2573EA
10 mg/20 mg/30 mg.
H02350A H02351A H02352A H02366A H02368A
H02378A H02382A H02379A H02386A H02395A
H02387A

2020 General Conformity Certificate identified by corresponding finished drug product batch number.

30mg.
F2604A F2605A F2616A F2617A F2620A
F2622B F2624AA F2621A F2623A F2625AA
F2618A F2633A F2619A F2609BA F2643A
F2644A F2639A
10mg/20mg/30mg.

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