Maple Grove, Minn. – September 30, 2026 -- Upsher-Smith Laboratories, LLC has launched Fluvoxamine Maleate Extended-Release Capsules in 100 mg and 150 mg strengths, entering a U.S. market valued at approximately $44.6 million according to IQVIA data covering August 2025 through July 2026.
Upsher-Smith secures AB-rated status against branded Luvox CR
The product carries a Therapeutic Equivalence (TE) code of AB, with Luvox CR designated as the Reference Listed Drug. The AB rating allows the generic to be considered therapeutically equivalent and substitutable for the brand-name extended-release formulation in U.S. pharmacy channels.
Bora Pharmaceuticals subsidiary expands U.S. generics portfolio
Upsher-Smith operates as a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX), a pharmaceutical services company that combines contract development and manufacturing (CDMO) operations with commercial drug distribution under what it terms a 'Dual Engine' model. The Fluvoxamine ER launch adds to Upsher-Smith's existing lineup of generic and branded pharmaceutical products supplied to U.S. customers.
Product carries Boxed Warning requirements for prescribers
Upsher-Smith has directed healthcare providers and patients to full prescribing information, including a Boxed Warning, available through the company or by phone request. The company has also established a dedicated adverse-event reporting line separate from standard FDA MedWatch channels, reflecting standard post-market surveillance protocols for this drug class.