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Adalvo Restarts DCP Procedure for Mirabegron Prolonged Release Tablets

08 May 2024

Adalvo announces the restart of the DCP procedure for Mirabegron 50 mg prolonged-release tablets with an anticipated EU Marketing Authorisation Approval date in July 2024.

Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency and urgency incontinence.

According to IQVIA, Mirabegron sold approximately $3.3Bn in global sales, in 2023 with a 3Y CAGR of 2%.

Based on the latest regulatory submissions, Adalvo expects to obtain marketing authorisation approvals that will be made available to our partners.

Adalvo is one of the few companies able to complete this very difficult development of a complex product in the generic pharma space, which further showcases our ability to bring differentiated products to our partners.

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