Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (ALPMF.PK), announced that the U.S. Food and Drug Administration or FDA has approved Myrbetriq or mirabegron extended-release tablets for the treatment of overactive bladder or OAB with symptoms of urge urinary incontinence, urgency and urinary frequency.
The company said the recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily.
Myrbetriq (mirabegron) is a beta- 3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Myrbetriq will be supplied in 25 mg and 50 mg tablets and is expected to be available in pharmacies in the fourth quarter of 2012. Mirabegron was approved in Japan in July 2011, and regulatory applications are under review in several other countries.
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