Upsher-Smith Launches Haloperidol Tablets, USP
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(TM) 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.
View original content to download multimedia:http://www.prnewswire.com/news-releases/upsher-smith-launches-haloperidol-tablets-usp-300985540.html
SOURCE Upsher-Smith Laboratories, LLC
