OTC Decisions November-December: GSK Labels For Nexium Promotion, Voltaren 2-Pack Approved
Aleve Design Refresh, Men's Rogaine Matching Women's Labeling Also Approved By FDA
Approvals by FDA also include revised container and consumer information labeling for J&J's Men’s Rogaine to align with labeling for Women’s Rogaine; bonus-pack labeling for Bayer AG’s Aleve; and
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Consultant Susan Levy points out Alcon’s Pataday eye drops and GSK's Voltaren Arthritis Relief as examples of effective switch advertising, marketing and management. Pfizer’s Advil line has been available far longer but also is an example of effective nonprescription brand management.
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.
OTC Decisions In April: Naproxen CV Risk Warning, Sun US Line Rises, Perrigo Omeprazole 'Melt In Mouth' Flag
The first US approvals for adding cardiovascular risk warnings to OTC naproxenb products were for the Aleve line of multiple formulations and delivery formats and in multiple container sizes and Biopharma and Catalent 220-mg capsules. Sun Pharma extends into expectorant/allergy and diarrhea remedy spaces in US OTC market.