EC approves Allergan's Ozurdex

Allergan Inc. (NYSE:AGN) said the European Commission approved an MAA for Ozurdex dexamethasone intravitreal implant to treat macular edema following retinal vein occlusion. Allergan plans to launch the biodegradable implant in Europe this quarter.

Allergan also said that FDA extended by three months the PDUFA date for an sBLA for Botox onabotulinumtoxinA to treat chronic migraine. Allergan had submitted a modified REMS for the product at FDA's request. Botox is approved in the U.S. to treat severe primary axillary hyperhidrosis, cervical dystonia and strabismus, blepharospasm associated with dystonia and upper limb spasticity. The PDUFA date is not disclosed. ...