Bayer wins Claritin labeling approval; registers Mexico finerenone real-world study
FDA cleared a labeling supplement for Claritin as Bayer opened an observational finerenone trial in Mexican primary care.
Bayer had two items on the registries this week, one regulatory and one observational.
- The FDA approved a supplement for Claritin (loratadine), covering Claritin tablets and Claritin Hives Relief tablets, both 10mg oral formulations, under NDA019658, submission number 64, a standard-priority labeling submission that was approved with a status date of 2026-09-25.1
- Bayer registered "Clinical Profile, Treatment Patterns and Evolution of the Urinary Albumin-to-creatinine Ratio in Patients With Type 2 Diabetes and Chronic Kidney Disease Treated With Finerenone at the Primary Care of the IMSS" (NCT07841015, acronym FINE-IMSS-MX). The study is not yet recruiting, with an estimated start of 2026-09-30 and primary completion set for 2027-12-31.2 It is an observational study in which the study does not decide or assign treatment, with participants receiving finerenone only if their primary care doctor has already decided to prescribe it, and dosing decisions left to the treating physician.2 Bayer plans to enroll participants in a single study group and follow them for up to 12 months after starting finerenone,2 with an estimated enrollment of 800 participants.2
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