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

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Upsher-Smith

Oct 23, 2018, 16:11 ET

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.

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Clobazam Tablets, CIV, 10 and 20 mg. Clobazam Oral Suspension, CIV, 2.5 mg/mL. Upsher-Smith Laboratories, LLC
Clobazam Tablets, CIV, 10 and 20 mg. Clobazam Oral Suspension, CIV, 2.5 mg/mL. Upsher-Smith Laboratories, LLC

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 100th 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.

SOURCE Upsher-Smith

Related Links

http://www.upsher-smith.com

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