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.
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Bausch + Lomb’s PreserVision supplement sales grew 17% in Q3, driving 11% growth its US consumer health business. CEO Joseph Papa says Bausch is “making great progress and expect the internal organization design” of its planned spin-off of Bausch + Lomb to be completed in a year.
“We selected Lumify based on its strong business performance in years one and two, and the success it had in growing a category through premiumization," says Nielsen’s BASES leader, Ben Macedo.
CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.