References

1.Data on file. IQVIA Top Branded Oral Rx Medication. AbbVie Inc. November 2020.

2. SYNTHROID [package insert]. North Chicago, IL: AbbVie Inc.

3.Lomenick JP, Wang L, Ampah SB, et al. Generic levothyroxine compared with SYNTHROID in young children with congenital hypothyroidism. J Clin Endocrinol Metab. 2013;98(2):653-658.

4. Q&A on CGMP requirements. Food & Drug Administration. Accessed September 30, 2022.
https://www.fda.gov/drugs/pharmaceutical-quality-resources/qa-cgmp-requirements

5. Current Good Manufacturing (CGMP) Regulations. Food & Drug Administration. Accessed September 30, 2022. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

6. Data on file. SYNTHROID Patient AAU Mistaken User Analysis AbbVie Inc. 2021.

7. Data on file. SYNTHROID Rx Analyst AbbVie Inc. October 2020.

8.Approved drug products with therapeutic equivalence evaluations. 42nd ed. US Department of Health and Human Services. Published 2022. Accessed September 30, 2022. https://www.fda.gov/media/71474/download

9.Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism [published correction appears in Endocr Pract. 2008;14(6):802-803]. Endocr Pract. 2002;8(6):457-469.

10. National Association of Boards of Pharmacy. 2022 Survey of Pharmacy Law. Mount Prospect, IL; 2022.

11.Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988-1028.

12.Demers LM, Spencer CA, eds. National Academy of Clinical Biochemistry. Laboratory medicine practice guidelines: laboratory support for the diagnosis and monitoring of thyroid disease. Accessed September 30, 2020. https://www.aacc.org/-/media/Files/Science-and-Practice/Practice-Guidelines/Thyroid-Disease/ThyroidArchived2010.pdf

13. Data on file. Managed Markets Insights & Technology (MMIT). Formulary Extracts of Synthroid. September 2022.

14.Data on file. SYNTHROID Insured Claim Co-pay Distribution. AbbVie Inc. January 2021.

15.Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160:526-534.

16.Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment. Clin Endocrinol (Oxf). 1988;28(3):325-333.

17.Alexander EK, Pearce EN, Brent GA, et al. 2017 Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2017;27(3):315-389.

18.Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87(2):489-499.

1.SYNTHROID [package insert]. North Chicago, IL: AbbVie Inc.

2. American Thyroid Association. Hypothyroidism. A booklet for patients and their families.
http://thyroid.org/wpcontent/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf. Published 2013.

3.Demers LM, Spencer CA, eds; National Academy of Clinical Biochemistry. Laboratory medicine practice guidelines: laboratory support for the diagnosis of thyroid disease https://www.aacc.org/-/media/Files/Science-and-Practice/Practice-Guidelines/Thyroid-Disease/ThyroidArchived2010.pdf. Accessed October 15, 2020.

4.Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American
Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism. Endocr Pract. 2002;8(6):457-469.

5.Yu LX, Jiang W, Zhang X, et al. Novel bioequivalence approach for narrow therapeutic index drugs. Clin Pharmacol Ther. 2015;97(3):286-291.

6.Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988-1028.

7.Data on file. IQVIA Top Branded Oral Rx Medication. AbbVie Inc. January 2018.

8.Lomenick JP, Wang L, Ampah SB, et al. Generic levothyroxine compared with Synthroid in young children with congenital hypothyroidism. J Clin Endocrinol Metab. 2013;98(2):653-658.

9.Data on file. Branded Drugs & Thyroid Market and Naturals. AbbVie Inc. 2015.

10.US Food and Drug Administration. Q&A on CGMPs. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm124740.htm.

11.US Food and Drug Administration. Current Good Manufacturing Practice Regulations. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

12.Data on file. 37% Data. AbbVie Inc.

13.DMD Pharmacy Rx Analyst Audit Report 2017.

14.Delta Marketing Dynamics. DMD Synthroid Rx Audit Summary, August 2017.

15.US Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 40th ed. Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research; 2020.
https://www.fda.gov/media/71474/download. Accessed October 15th, 2020.

16.Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160:526-534.

17.Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment. Clin Endocrinol (Oxf). 1988;28(3):325-333.

18.Alexander EK, Pearce EN, Brent GA, et al. 2017 Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2017;27(3):315-389.

19.Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87(2):489-499.