Miraberon API Receives FDA Registration Approval
August 12, 2026
Source: drugdu
26
China Securities Intelligent Finance - Tonghe Pharmaceutical(300636) announced on the evening of August 11 that the company recently received Miraberon API issued by the U.S. Food and Drug Administration.The NFC Letter indicates that the FDA has completed its technical review of the company's DMF file for the Miraberon active pharmaceutical ingredient , which meets the ANDA application requirements of related formulation customers.
The announcement indicates that mirabezone is a selective β3-adrenergic receptor agonist that can improve bladder filling and storage capacity by activating β3-adrenergic receptors on the bladder detrusor muscle. Clinically, it is used to treat overactive bladder with symptoms such as urge incontinence, urgency, and frequency.
The company stated that the successful technical review of Mirabelon API will facilitate market expansion and customer acquisition, and will play a positive role in further expanding the company's international business.
https://finance.eastmoney.com/a/202608113837991159.html
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