MyrbetriqTreatment for Overactive Bladder
Update: Myrbetriq (mirabegron) Now FDA Approved - June 28, 2012
Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178)
Tokyo, November 11, 2011 - Astellas Pharma Inc. (Tokyo: 4503, “Astellas”) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) indicating that it accepted for filing the New Drug Application for mirabegron (generic name / code name: YM178) and initiated a substantive review. The target date for the review completion (PDUFA date) is June 29, 2012.
A similar letter from the European Medicines Agency (EMA) validating the application and confirming the start of the review procedure was received.
The submissions were sent on August 24 and 26, 2011 (to the EMA and the FDA, respectively). Astellas is seeking approval for this first in a new class of medicine for the indication of overactive bladder (OAB) associated with symptoms of urgency, urinary frequency, and urge urinary incontinence.
Posted: November 2011
- FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms - May 7, 2018
- FDA Approves Myrbetriq for Overactive Bladder - June 28, 2012
- FDA Advisory Committee Recommends Approval of Mirabegron - Investigational Overactive Bladder Treatment from Astellas - April 5, 2012
- Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe - August 29, 2011