FDA seeks answers before approving drug

Irvine, CA-Allergan Inc. is continuing to evaluate a clinical study of its brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% (Combigan) in an effort to address FDA questions prior to final marketing approval.

The company announced in late December that the FDA had issued an approvable letter for the drug, indicated to reduce elevated IOP in patients with glaucoma or ocular hypertension. An approvable letter outlines the remaining conditions a company must meet to obtain final FDA approval.

In its letter, the FDA suggested an additional confirmatory study to address certain questions. Allergan said it had begun that study in late 2005 and that it should address those questions.