Perrigo Feeds OTC Brand Play With Prevacid As GSK Thins Consumer Lineup
Already providing generic equivalents, Perrigo buys national brand from GSK as it acts on commitment to move into brand product sales. Plans to expand OTC Prevacid line, likely with an orally disintegrating tablet, and to grow entire US OTC gastrointestinal category.
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FDA approves request after Nexium 24HR marketer Haleon responded March to changes-being-effected letter asking for label change to the delayed-release PPI.
CDER’s August-September OTC application approvals are highlighted by Arbor Pharmaceuticals’ ivermectin 0.5% lice treatment. Orange Book changes also include four firms’ approvals for labeling to market generic equivalents of Voltaren Arthritis Relief launched as an OTC switch since earlier in 2020.
Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.