Aleve Has A ‘Headache’ For Proprietary Brand And As First Indication On Labeled Uses List

US FDA approves Bayer HealthCare's supplemental NDA for adding Aleve Headache Pain proprietary name to use with the brand’s regular strength formulation, naproxen 220 mg. The approval also allows moving headache to top of indications list.

Nov 2, 2019 San Francisco / CA / USA - Bayer offices located in Mission Bay District; Bayer AG is a German multinational pharmaceutical and life sciences company, one of the largest in the world

The Aleve OTC brand is synonymous with the ingredient naproxen’s indication of physical pain, but Bayer AG has US approval for “Headache Pain” branding with headache at the top of the list of labeled uses.

The Food and Drug Administration on 8 May submitted to Bayer HealthCare LLC an approval for its December 2019...