Allergan Inc announced that the US Food and Drug Administration (FDA) has issued an approvable letter for its Lumigan timolol combination product for glaucoma (bimatoprost 0.03 per cent/timolol 0.05 per cent ophthalmic solution). An approvable letter sets out the conditions that a company must meet in order to obtain FDA final marketing approval.
"The FDA's response necessitates additional clinical investigation," explained Dr. Scott Whitcup, Allergan's executive vice president, Research and Development. "Allergan has already initiated an additional clinical study that we currently anticipate will be completed by the end of 2004," he added.
Allergan Inc is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets.