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Upsher-Smith Launches Propafenone Hydrochloride Extended-Release Capsules

Maple Grove, MN – June 30, 2020 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Propafenone Hydrochloride Extended-Release Capsules in 225 mg, 325 mg and 425 mg strengths. Upsher-Smith’s product is AB-rated to the branded product, RYTHMOL® SR (propafenone hydrochloride extended-release capsules)*.

The propafenone hydrochloride extended-release capsule market had U.S. sales of approximately $51 million for the 12 months ending May 2020 according to IQVIA.

Product Information

Product

Strength

NDC #

Package Size

Propafenone Hydrochloride ER Capsules

225 mg

0832-0740-60

60-count bottle

Propafenone Hydrochloride ER Capsules

325 mg

0832-0741-60

60-count bottle

Propafenone Hydrochloride ER Capsules

425 mg

0832-0742-60

60-count bottle

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

WARNING: MORTALITY

• In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months.

• The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.

Please refer to the full Prescribing Information, including Boxed Warning for Propafenone Hydrochloride Extended-Release Capsules 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 begins its second century in business, 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™ for the patients they serve. For more information, visit www.upsher-smith.com.

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*RYTHMOL SR is a trademark owned by or licensed to the GSK group of companies.

Do More Good is a trademark of Upsher-Smith Laboratories, LLC.

PM-000783