Mar 27, 2019   SOURCE: PR NewsWire

Upsher-Smith Launches Generic Version Of Prozac® (fluoxetine) Tablets

MAPLE GROVE, Minn., March 27, 2019 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Fluoxetine Tablets, USP, 10 and 20 mg. Upsher-Smith's product is AB-rated to the branded product, Prozac(® )(fluoxetine) tablets, USP*.

The 10 and 20 mg fluoxetine tablet market had U.S. sales of approximately $69 million for the 12 months ending December 2018 according to IQVIA.

Product Information 

       
        
              Product        Strength 
       
              NDC # 
       
            Package Size

               ---

     
       Fluoxetine Tablets, USP 
     10 mg         
       0832-0402-30     
       30-count bottle

               ---

     
       Fluoxetine Tablets, USP 
     10 mg         
       0832-0402-11     
       100-count bottle

               ---

     
       Fluoxetine Tablets, USP 
     20 mg         
       0832-0403-30     
       30-count bottle

               ---

     
       Fluoxetine Tablets, USP 
     20 mg         
       0832-0403-11     
       100-count bottle

               ---

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

                     WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
                  See full prescribing information for complete boxed
                                        warning.



     Antidepressants increased the risk of suicidal thoughts and
      behavior in children, adolescents, and young adults in
      short-term studies. These studies did not show an
      increase in the risk of suicidal thoughts and behavior
      with antidepressant use in patients over age 24; there was
      a reduction in risk with antidepressant use in patients
      aged 65 and older.  
              
                In patients of
      all ages who are started on antidepressant therapy,
      monitor closely for worsening and for emergence of
      suicidal thoughts and behaviors. Advise families and
      caregivers of the need for close observation and
      communication with the prescriber.
      Fluoxetine is not approved for use in children less than 7
      years of age.


                    When using fluoxetine and olanzapine in combination, also
                     refer to Boxed Warning section of the package insert for
                                            Symbyax(R).

                            ---

Please refer to the full Prescribing Information, including Boxed Warning for Fluoxetine 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.

*Prozac is a registered trademark of Eli Lilly and Company. Prozac(®) (fluoxetine) Tablets have been discontinued.

114017.01

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SOURCE Upsher-Smith Laboratories, LLC