FDA approves Allergan's Botox for OAB and NuPathe's Zecuity for migraine

US drugmaker Allergan (NYSE: AGN) says that the US Food and Drug Administration has approved its Botox (onabotulinumtoxinA), best known as an anti-wrinkle preparation,  for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton Joffe, director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research, on Friday, adding: “Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”

$200 million added sales forecast from OAB indication