Allergan receives approvable letter from FDA

Combigan has been developed for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension and is already marketed in Europe, Canada, Brazil and Australia. The FDA has suggested an additional confirmatory study from Californian-based Allergan to answer questions about the therapy posed by the agency.

Allergan’s executive vice president for R&D, Scott Whitcup, said: “We remain committed to the program and to working diligently with the FDA on any remaining issues. Allergan already commenced a clinical study at the end of 2005 that addresses the remaining FDA questions.”