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Upsher-Smith Kicks off 2020 with Three Generic Product Launches

Company Strengthens Its Generic Portfolio with Rapid Product Expansion

Maple Grove, MN – February 19, 2020 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has expanded its generic portfolio with the recent launch of three new products: Fluvoxamine Maleate Tablets, Haloperidol Tablets, USP, and Clonidine Hydrochloride Extended-Release Tablets. The market for these three products had combined U.S. sales of nearly $102.5 million for the twelve months ending December 2019, according to IQVIA. The Company has committed itself to aggressively growing the number of generic programs in its portfolio. Over the next few years, through both internal research and development and external partnerships, Upsher-Smith will substantially expand its pipeline. This effort is being supported by an investment in infrastructure with the construction of a state-of-the-art, efficient, high-quality manufacturing facility at its Minnesota headquarters.

“We enter this new decade not only with our most aggressive growth plan in history, but also prepared to meet the challenging market conditions that lie ahead,” said Rusty Field, President and CEO, Upsher-Smith. “We’re proud of our strong reputation as a trusted partner in the generic marketplace and look forward to delivering even more affordable options to patients and healthcare professionals.”

Product Information

For questions about ordering Fluvoxamine Maleate Tablets, Haloperidol Tablets, USP, and Clonidine Hydrochloride Extended-Release Tablets, please call Upsher-Smith at 1-800-654-2299. 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.

Boxed Warning for Fluvoxamine Maleate Tablets

WARNING: SUICIDALITY AND ANTIDEPRESSANTS
See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. Fluvoxamine maleate is not approved for use in pediatric patients except those with obsessive compulsive disorder.

Boxed Warning for Haloperidol Tablets, USP

WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular
(e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

Please refer to the full Prescribing Information, including Boxed Warnings for Fluvoxamine Maleate Tablets and Haloperidol Tablets, USP. Click here for full Prescribing Information for Clonidine Hydrochloride Extended-Release Tablets. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information for each product.

About Upsher-Smith

Upsher-Smith Laboratories, LLC 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. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.

As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More GoodTM for the patients they serve.

Do More Good is a trademark of Upsher-Smith Laboratories, LLC.