FDA sets target date for completing OAB drug review

December 1, 2011

Astellas Pharma, Inc, has announced the receipt of a letter from the FDA indicating that it accepted for filing the new drug application for mirabegron (YM178) and initiated a substantive review.

Astellas Pharma, Inc, has announced the receipt of a letter from the FDA indicating that it accepted for filing the new drug application for mirabegron (YM178) and initiated a substantive review.

Astellas is seeking approval for mirabegron for the indication of overactive bladder associated with symptoms of urgency, urinary frequency, and urge incontinence.

The target date for the review completion is June 29, 2012.A similar letter from the European Medicines Agency validating the application and confirming the start of the review procedure was also received, the company said.

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