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Glaucoma

Allergan reports U.S. FDA issues approvable letter for Combigan

Published in Medical Letter on the CDC and FDA, January 28th, 2007

Allergan, Inc., (AGN) announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.

An approvable letter outlines the remaining conditions that a company must meet in order to obtain FDA final marketing approval.

"We remain committed to the program and to working diligently with the FDA on any remaining issues," said Scott M. Whitcup, MD, Allergan's executive...

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