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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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.
After most of the big pharmaceutical companies reported their full-year 2019 financial results, the second month of earnings season brings the long tail of smaller biotech companies and the generic pharmaceutical companies. There is more than one uncomfortable parallel from the former in the reports of the latter.