Jiangxi Synergy Pharmaceutical Co.,Ltd. (300636.SZ) announced it has received a DMF No Further Comments Letter (NFC Letter) from the U.S. Food and Drug Administration (FDA) for its mirabegron active pharmaceutical ingredient (API).

Mirabegron, a selective beta-3 adrenergic receptor agonist, enhances bladder filling and storage capacity by activating beta-3 adrenergic receptors on the detrusor muscle. It is clinically used to treat overactive bladder symptoms including urgency urinary incontinence, urinary urgency, and increased frequency of urination.