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

Executive Summary

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.

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Bausch Shines Planned Spin-Out, Launches First US Preservative-Free OTC Antihistamine Eye Drops

Bausch + Lomb’s Alaway Preservative-Free antihistamine eye drops launch in US, The Bausch Health Companies division planned as spin-out also recently gained South Korean approval for its Lumify OTC redness reliever drops and has submissions under review in other countries.

With Preservative-Free Alaway Eye Drops, Bausch Expands OTC Portfolio Of Planned Spin-Off

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 

Included In Bausch’s Planned Spin-Off, Consumer Brands Account For 3 Spots In Its Top 10 List

Sales of its segment leaders Ocuvite and PreserVision vision health supplements, Lumify OTC eye drops and other consumer lines were down a reported 13% to $321m in the second quarter.

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