Oct 23, 2018   SOURCE: PR NewsWire

Upsher-Smith Launches Generic Version Of Onfi® (clobazam), CIV In Tablet And Oral Suspension Dosage Forms

MAPLE GROVE, Minn., Oct. 23, 2018 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Clobazam Tablets, CIV, 10 and 20 mg and Clobazam Oral Suspension, CIV, 2.5 mg/mL. Upsher-Smith's Clobazam products are AB-rated to the branded products, Onfi(® )(clobazam) tablets, CIV and Onfi(®) (clobazam) oral suspension, CIV.

The clobazam tablet market had U.S. sales of approximately $594 million for the 12 months ending August 2018, and the clobazam oral suspension market had U.S. sales of approximately $255 million for the 12 months ending August 2018 according to IQVIA.

"Upsher-Smith's generic Clobazam will provide patients and families with a generic alternative to Onfi(®)," said Rusty Field, President and CEO, Upsher-Smith. "The approval and launch of this product in both tablet and oral suspension forms offers yet another example of our commitment to growing and diversifying our generics portfolio."

Product Information 

             Product          Strength          NDC #            Package Size

     ---

       Clobazam
       Tablets,
          CIV          
       10 mg       0832-0580-11   
       100 count bottle

     ---

       Clobazam
       Tablets,
          CIV          
       20 mg       0832-0581-11   
       100 count bottle

     ---

       Clobazam
         Oral
      Suspension,
          CIV        
       2.5 mg/mL     0832-0585-25     
       120 mL bottle

     ---

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

                 WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS


                       See full prescribing information for complete boxed
                                              warning.




        Concomitant use of benzodiazepines and opioids may
         result in profound sedation, respiratory
         depression, coma, and death.

        Reserve concomitant prescribing of these drugs for
         use in patients for whom alternative treatment
         options are inadequate.
         Limit dosages and durations to the minimum
         required. 
              
                Follow patients
         for signs and symptoms of respiratory depression
         and sedation.

    ---

Please refer to the full Prescribing Information, including Boxed Warning for Clobazam Tablets, CIV here and for Clobazam Oral Suspension, CIV 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. As we approach our 100(th) year in business, we enter a new ambitious era that has been accelerated by our 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Together, we seek to deliver the best value for our stakeholders, and most importantly, do more good for the patients we serve.
For more information, visit www.upsher-smith.com

Onfi is a registered trademark of Lundbeck.

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SOURCE Upsher-Smith