Exclusivity Awaits OTC Ibuprofen-Acetaminophen Combination As Safety Concerns Trail Ingredients
GSK will market Advil Dual Action with Acetaminophen noting potential risks for both of the product’s active ingredients with labeling highlights FDA requires. It can counter labeling about risks by noting studies show the combination has better efficacy than larger doses of each drug used separately.
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CDER approves Bayer Healthcare’s azelastine 0.15% nasal antihistamine indicated for seasonal and perennial allergic rhinitis in adults and children 6 and older. Bayer says Astepro Allergy is first steroid-free antihistamine for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief.
Wellness products accounted for the highest number of launches among health, wellness and beauty products at independent pharmacies in 2020. But the overall number slumped 21.1% due to the pandemic, according to Hamacher Resource Group’s report on a product rating system.
Rx-to-OTC switches of the painkillers dexibuprofen and single-pill combinations of ibuprofen and paracetamol as well as the cough medicine levodropropizine, all for oral use, will be considered at the next German Expert Committee for Prescription meeting on 13 July.