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Upsher-Smith Laboratories LLC and Rafarm SA have announced the U.S. commercial launch of moxifloxacin ophthalmic solution, USP 0.5% following a recent abbreviated new drug application (ANDA) approval by the FDA.
Upsher-Smith Laboratories LLC and Rafarm SA 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 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.
Rusty Field, president and CEO of Upsher-Smith, explained that the launch of Moxifloxacin is significant because it represents a series of firsts for 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,” he said in a statement. “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 pointed out that the Upsher-Smith and Rafarm teams work extraordinarily well together and that has allowed the companies to establish a strong partnership.
“Our manufacturing capabilities, coupled with Upsher-Smith's rich understanding of the U.S. generics market, will ensure that patients receive quality, affordable medicines,” he said.