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