Adalvo proudly announces the addition of Mirabegron/Solifenacin Prolonged Release Tablets to our product list, set to be submitted for regulatory approval in Q1 2025.
Developed in collaboration with one of our strategic partners, this product will offer a solution for symptomatic treatment of urgency, increased micturition frequency, and/or urgency incontinence in adult patients with overactive bladder (OAB) syndrome.
Mirabegron/Solifenacin Prolonged Release Tablets will come in strengths of 25/5mg & 50/5mg and are based on the innovator brands Betmiga Prolonged Release Tablets (Mirabegron) and Vesicare Film-Coated Tablets (Solifenacin).
Backed by robust clinical data, Mirabegron/Solifenacin PR Tablets have shown superior efficacy and safety in managing the symptoms of OAB syndrome during initial studies. With a combined global 2023 IMS MAT sales of $3.6 Billion, according to IQVIA, Mirabegron/Solifenacin PR Tablets represent a significant opportunity as a value-added medicine (505b2/hybrid).
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