References
1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023. 2. JATENZO® [medication guide]. Fort Collins, CO: Tolmar; 2023.
1. Data on file. JATENZO QBR Analytics Update — FOLLOW UP for Switchers. November 11, 2020. Tolmar, Inc. 2. Data on file. The Harris Poll. Hypogonadism Patient Research: Executive Summary (conducted May 6-June 5, 2020). Tolmar, Inc.
1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023. 2. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc. (per FDA Guidance*) 3. Swerdloff RS, Wang C, White WB, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531. 4. Data on file. Clinical Study Report: CLAR-18019. Tolmar, Inc. (per FDA Guidance*) 5. Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64:663-664. 6. Data on file. Clinical Study Report: CLAR-09009. Tolmar, Inc. (per FDA Guidance*) 7. Data on file. Clinical Study Report: CLAR-09007. Tolmar, Inc. (per FDA Guidance*) 8. Swerdloff R, et al. Monitoring testosterone (T) levels in men receiving oral testosterone undecanoate (TU): challenges due to post-collection conversion of TU-to-T and a path forward. Presented at: Endocrine Society Annual Meeting (ENDO 2019); March 23-26, 2019; New Orleans, LA. Abstract SUN-227. 9. Swerdloff R, et al. Efficacy and safety of a new oral testosterone undecanoate (TU) formulation in hypogonadal men: results from the ‘inTUne’ trial. Presented at: Endocrine Society Annual Meeting (ENDO 2018); March 18, 2018; Chicago, IL. Abstract SUN-249. 10. Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103:1715-1744.
*Guidance for Industry: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers (June 2018).
1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023. 2. JATENZO® [medication guide]. Fort Collins, CO: Tolmar; 2023. 3. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc. (per FDA Guidance*) 4. Swerdloff RS, Wang C, White WB, Kaminetsky J, Gittelman MC, Longstreth JA, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531. 5. Data on file. Tolmar, Inc; BRUDAC Presentation. January 9, 2018. 6. Petering RC, Brooks NA. Testosterone therapy: review of clinical applications. Am Fam Physician. 2017;96(7):441-449. 7. Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Trans Androl Urol. 2016;5(6):834-843.
*Guidance for Industry: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers (June 2018).
1. JATENZO [prescribing information]. Northbrook, IL: Tolmar, Inc.; 2019. 2. JATENZO [medication guide]. Northbrook, IL: Tolmar, Inc.; 2019. 3. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc. (per FDA Guidance*) 4. Swerdloff RS, Wang C, White WB, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531.
*Guidance for Industry: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers (June 2018).