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

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     Haloperidol
     Tablets, USP    
      0.5 mg       0832-1510-11   
     100-count bottle

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     Haloperidol
     Tablets, USP     
      1 mg        0832-1520-11   
     100-count bottle

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     Haloperidol
     Tablets, USP     
      2 mg        0832-1530-11   
     100-count bottle

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     Haloperidol
     Tablets, USP     
      5 mg        0832-1540-11   
     100-count bottle

     ---

     Haloperidol
     Tablets, USP     
      10 mg       0832-1550-11   
     100-count bottle

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     Haloperidol
     Tablets, USP     
      20 mg       0832-1560-11   
     100-count bottle

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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.

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SOURCE Upsher-Smith Laboratories, LLC