Upsher-Smith Laboratories, LLC (Upsher-Smith) and Rafarm S.A. (Rafarm) today announced the U.S. commercial launch of Moxifloxacin Ophthalmic Solution, USP 0.5% following a recent abbreviated new drug application (ANDA) approval by the U.S. Food and Drug Administration (FDA). Moxifloxacin Ophthalmic Solution is equivalent to the branded product Vigamox®
| MAPLE GROVE, Minn. and ATHENS, May 27, 2021 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) and Rafarm S.A. (Rafarm) today announced the U.S. commercial launch of Moxifloxacin Ophthalmic Solution, USP 0.5% following a recent abbreviated new drug application (ANDA) approval by the U.S. Food and Drug Administration (FDA). Moxifloxacin Ophthalmic Solution is equivalent to the branded product Vigamox®.
In 2018, Upsher-Smith and Rafarm entered into a partnership agreement to develop and distribute six ophthalmic and otic ANDA products. Under the agreement, Upsher-Smith is responsible for registering the products with the FDA and marketing and distributing them under its own label in the U.S. upon FDA approval. Rafarm is responsible for the development and manufacturing of the products exclusively for Upsher-Smith. The moxifloxacin ophthalmic market had U.S. sales of approximately $34 million for the 12 months ending March 2021 according to IQVIA. “The launch of Moxifloxacin is significant because it represents a series of firsts for Upsher-Smith,” said Rusty Field, President and CEO of Upsher-Smith. “It is not only our first ophthalmic product to enter the market, but also the first product resulting from our partnership with Rafarm. We are very pleased to have partnered with Rafarm and proud of the successful relationship we’ve built together. We look forward to building upon that success as we expand our portfolio to include both ophthalmic and otic agents.” Aris Mitsopoulos, Executive Vice President of Rafarm said, “The Upsher-Smith and Rafarm teams work extraordinarily well together and that has allowed us to establish a strong partnership. Our superb manufacturing capabilities, coupled with Upsher-Smith’s rich understanding of the U.S. generics market, will ensure that patients receive quality, affordable medicines.” Product Information
For questions about ordering, please call Upsher-Smith at 1-800-654-2299. Please refer to the full Prescribing Information for Moxifloxacin Ophthalmic Solution, USP 0.5% 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 its founding in 1919, and continuing with its acquisition by Sawai Pharmaceutical Co., Ltd. in 2017, Upsher-Smith has brought generics and brands to a wide array of customers, always backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com. About Rafarm Rafarm is a fully integrated pharmaceutical company specialized in ophthalmic and complex injectable products, putting into practice business beliefs which include high quality medicines at affordable prices. The company was established in 1972 in Greece and has partnerships with leading companies in Europe and in more than 60 countries all over the world, including the U.S., Canada and Australia. The Company continuously invests in technology and implements the strictest standards of quality in every phase of development and production. A large investment program is in progress that will enable Rafarm to expand its capabilities and produce medicines with highly advanced technological specifications. For more information, visit https://www.rafarm.gr. # # # Vigamox® is a registered trademark of Alcon, Inc.
SOURCE Upsher-Smith Laboratories, LLC |
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