FDA issues approvable letter for Allergan's Combigan

Washington, DC-The FDA has issued an approvable letter for brimonidine tartrate/timolol maleate ophthalmic solution (Combigan, Allergan Inc.), outlining the remaining conditions that the company must meet to obtain final marketing approval from the agency.

The Irvine, CA, company aims to market the solution in the United States as adjunctive or replacement therapy to reduce elevated IOP in patients with glaucoma or ocular hypertension. The drop already is approved and marketed in Europe, Canada, Brazil, and Australia.

“In its approvable letter, the FDA suggested an additional confirmatory study to address certain questions,” said Scott M. Whitcup, MD, Allergan’s executive vice president, research and development. “Allergan already commenced a clinical study at the end of 2005 that addresses the remaining FDA questions.”

The company is committed to working with the FDA on any remaining issues, he said.

The two agents in Combigan, brimonidine tartrate ophthalmic solution 0.2% (Alphagan) and timolol ophthalmic solution 0.5%, a beta blocker, already have been shown to reduce IOP.