Medical Letter on the CDC & FDA
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC & FDA
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Glaucoma
Approvable letter issued by FDA for Lumigan
September 5th, 2004
Allergan, Inc., (AGN) 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%/timolol 0.05% ophthalmic solution). An approvable letter sets out the conditions that a company must meet to obtain FDA final marketing approval. "The FDA's response necessitates additional clinical investigation," explained Scott Whitcup, Allergan's executive VP, research and development. "Allergan has already initiated an additional clinical study that we currently anticipate will be completed by the end of 2004," Whitcup said. ...
Source: Medical Letter on the CDC & FDA (2004-09-05)
|
