Upsher-Smith Launches Fluvoxamine Maleate Extended-Release Capsules
Upsher-Smith Laboratories, LLC, a well-established subsidiary of Bora Pharmaceuticals, has recently announced the launch of its Fluvoxamine Maleate Extended-Release Capsules, available in 100 mg and 150 mg strengths. This launch marks a significant addition to the pharmaceutical landscape aimed at addressing mental health needs for patients dealing with mood disorders.
The U.S. market for Fluvoxamine Maleate Extended-Release has shown promising sales, reportedly reaching approximately $44.6 million according to IQVIA analytics. The product's Therapeutic Equivalence (TE) code is AB, and it is classified under the reference drug Luvox CR.
Product Details
- - Strengths Available: 100 mg and 150 mg
- - NDC Numbers:
- 100 mg: 0832-6025-30
- 150 mg: 0832-6026-30
- - Packaging: Each strength is offered in bottles containing 30 capsules.
Prospective customers can inquire about ordering through Upsher-Smith's dedicated hotline at 1-800-654-2299. Alongside this launch, it is critical to highlight the product warnings concerning suicidality and antidepressant use.
Important Warnings and Safety Information
Clinical studies indicate that the use of antidepressants, including fluvoxamine, can elevate the risk of suicidal thoughts and behaviors, particularly in children, adolescents, and young adults. Thus, healthcare providers and families should vigilantly monitor patients for any signs of clinical deterioration or behavior changes, especially when initiating treatment. The response to treatment should be closely observed, and families are encouraged to maintain open dialogues with prescribers for ongoing assessment.
Studies have shown no increased risk of suicidality among adults over the age of 24, while a reduction in risk was noted in older adults aged 65 and above. This vital information plays a significant role in treatment decisions and patient care.
For comprehensive safety information, including a Boxed Warning, patients and caretakers are advised to consult the full prescribing information, which is accessible through the Upsher-Smith website. It is also encouraged to report any adverse reactions to the company or the FDA, thereby supporting patient safety and drug efficacy.
About Upsher-Smith Laboratories
Founded with the mission to deliver high-quality pharmaceutical products, Upsher-Smith Laboratories has increasingly focused on sustainability and innovation within the healthcare sector. The company continues to forge strong relationships across different industries, ensuring a stable supply of its medications.
As part of Bora Pharmaceuticals, which was established in 2007, Upsher-Smith aims to contribute to global health improvements through advanced drug formulation and development. Bora Pharmaceuticals operates under a Dual Engine model which merges contract development and manufacturing organization (CDMO) expertise with commercial acumen, enabling it to meet the global needs of patients more effectively.
For more details on Upsher-Smith's offerings and mission, visit
their official website or reach out for further inquiries. With each product launched, they reaffirm their dedication to improving patient outcomes and enhancing the quality of life for individuals with various health challenges.