Allergan Receives Approvable Letter for Lumigan -- bimatoprost-timolol
IRVINE, Calif., August 2, 2004 - Allergan, Inc. (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its Lumigan timolol combination product for glaucoma (bimatoprost 0.03 percent/timolol 0.05 percent 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."
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, 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 that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
For further information, please visit www.allergan.com
Posted: August 2004