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Bausch Expects US Approval In 2020 Of Preservative-Free OTC Ketotifen Eye Drop

 
• By Eileen Francis

Bausch says it expects US FDA to approve its ANDA for the first preservative-free OTC eye drop for ocular itching associated with allergic conjunctivitis in the second half of 2020. The firm reports its Lumify redness relief drops generated sales of $63m for 2019.

Eye

Bausch Health Companies Inc. expects US approval during the second half of 2020 of its application for the first preservative-free OTC eye drop containing ketotifen for the treatment of itching associated with allergic conjunctivitis.

Bausch submitted to the Food and Drug Administration an abbreviated new drug application for OTC use of preservative-free ketotifen, identified as investigational new drug EM-100, early in 2019 but in July

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• By Malcolm Spicer

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More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

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• By Derrick Gingery

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• By Malcolm Spicer

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