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Adalvo Announces Successful EU Approval for Mirabegron 50mg Prolonged-Release Tablets

Business
26 July 2024

Adalvo secures successful DCP approval for Mirabegron 50mg prolonged-release tablets. 

Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency, and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. 

According to IQVIA, Mirabegron achieved approximately $3.3Bn in global sales in 2023, with a 3-year CAGR of 2%

Additionally, registrations for Mirabegron 25mg are currently ongoing, demonstrating Adalvo's commitment to providing a wide range of treatment options.

Adalvo’s success in securing this approval reflects our capabilities to develop complex, differentiated products. Building on the success of Mirabegron, Adalvo is also progressing well with the development of Mirabegron+Solifenacin, further expanding our portfolio and enhancing treatment options for patients.

There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. 

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