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Upsher-Smith Launches Generic Version of Lomotil® (Diphenoxylate Hydrochloride and Atropine Sulfate) Tablets

Sep. 03. 2018

Maple Grove, MN –August 31, 2018 – Upsher-Smith Laboratories, LLC (Upsher-Smith, President and CEO: Rusty Field), a subsidiary of Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) announced the launch of Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP, 2.5 mg / 0.025 mg (the branded product: Lomotil®* ). The product was approved by the U.S. Food and Drug Administration (FDA) on August 31.

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets 2.5 mg / 0.025 mg is prescribed for adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

The diphenoxylate hydrochloride and atropine sulfate tablet market had U.S. sales of approximately $64 million for the 12 months ending May, 2018 according to IQVIA.

* Lomotil is a registered trademark of G.D. Searle LLC.

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, we’ve brought specialty generics and other products to a wide array of customers, backed by our attentive level of service, our strong industry relationships, and our dedication to uninterrupted supply. 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. With our new owner, we look to leverage each other for growth worldwide and embark on an exciting new chapter. 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 https://www.upsher-smith.com.