FDA Approvals of 2012

14 of 39


Drug: Myrbetriq
Generic molecule: mirabegron
Company: Astellas Pharma
Approval date: June 28

The scoop: This new leaky bladder treatment from Japanese drugmaker Astellas Pharma will sell into a market in the U.S. where an estimated 33 million to 44 million suffer from overactive bladders. Myrbetriq goes up against Pfizer's Detrol, Warner Chilcott's ($WCRX) Enablex, and, of course, its own Vesicare, which generated $1 billion in sales last year but which loses its patent in 2018. The advantage of the once-daily Myrbetriq is that it helps without affecting patients ability to urinate, like some competing drugs.