Upsher-Smith Launches Haloperidol Tablets, USP

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Jan 13, 2020, 09:00 ET

MAPLE GROVE, Minn., Jan. 13, 2020 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Haloperidol Tablets, USP in 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg and 20 mg strengths. Haloperidol Tablets are a generic version of the brand product, Haldol^®Tablets*.

The haloperidol tablet market had U.S. sales of approximately $41 million for the 12 months ending August 2019 according to IQVIA.

Product Information

Product	Strength	NDC #	Package Size
Haloperidol Tablets, USP	0.5 mg	0832-1510-11	100-count bottle
Haloperidol Tablets, USP	1 mg	0832-1520-11	100-count bottle
Haloperidol Tablets, USP	2 mg	0832-1530-11	100-count bottle
Haloperidol Tablets, USP	5 mg	0832-1540-11	100-count bottle
Haloperidol Tablets, USP	10 mg	0832-1550-11	100-count bottle
Haloperidol Tablets, USP	20 mg	0832-1560-11	100-count bottle

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

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 Warning for Haloperidol Tablets, USP 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 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 celebrates its 100-year anniversary, 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 Good™ for the patients they serve. For more information, visit www.upsher-smith.com.

*Haldol is a registered trademark of Johnson & Johnson Corp; Haldol Tablets have been discontinued.
Do More Good is a trademark of Upsher-Smith Laboratories, LLC.

SOURCE Upsher-Smith Laboratories, LLC