Combigen gets FDA approvable letter

California, USA-based pharmaceutical firm Allergan says that Combigan (brimonidine tartrate/timolol maleate opthalmic solution) 0.2%/0.5%, under development as a treatment for patients with glaucoma or ocular hypertension, is the subject on an approvable letter from the Food and Drug Administration. The company added that the agent, which is a combination drug designed to reduce elevated intraocular pressure in cases where it is inadequately controlled, is approved by regulatory authorities in Europe, Canada, Brazil and Australia.

Allergan's executive vice president of R&D, Scott Whitcup, said that, "in its approvable letter, the FDA suggested an additional confirmatory study to address certain questions posed by the agency." He added that a study, initiated by the company at the end of 2005, addresses the agency's remaining questions.