UPSHER-SMITH LAUNCHES FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES
PR Newswire
MAPLE GROVE, Minn., Sept. 30, 2026
MAPLE GROVE, Minn., Sept. 30, 2026 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith), a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX), today announced the recent launch of Fluvoxamine Maleate Extended-Release Capsules in 100 mg and 150 mg strengths. According to IQVIA, the Fluvoxamine Maleate Extended-Release market had U.S. sales of approximately $44.6 million*.
The Therapeutic Equivalence (TE) code for Upsher-Smith's Fluvoxamine Maleate Extended-Release product is AB, and the Reference Listed Drug (RLD) is Luvox CR.
Product Information
Product | Strength | NDC # | Size & Package |
Fluvoxamine Maleate Extended-Release Capsules | 100 mg | 0832-6025-30 | 30-ct bottle |
Fluvoxamine Maleate Extended-Release Capsules | 150 mg | 0832-6026-30 | 30-ct bottle |
For questions about ordering, please call Upsher-Smith at 1-800-654-2299.
WARNINGS: SUICIDALITY and ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. |
Please see additional Important Safety Information, including Boxed Warning, and full Prescribing Information for Fluvoxamine Maleate Extended-Release Capsules here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.
About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
About Bora
Founded in 2007, Bora Pharmaceuticals ("Bora" or "the Company", 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of "Contributing to Better Health All Over the World". Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.
By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries. For more, please visit: https://www.bora-corp.com and https://www.boracdmo.com.
*August 2025 – July 2026
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SOURCE Upsher-Smith Laboratories, LLC
