FDA Law Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of FDA Law Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Allergies
ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve(TM) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
June 18th, 2009
ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA), announced it has received notification from the U.S. Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) on June 26, 2009. On November 13, 2008, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The NDA filing includes data from ISTA's Phase III clinical studies with Bepreve. The Phase III studies demonstrated highly statistically significant reductions in the primary endpoints of ocular itching....
Source: FDA Law Weekly (2009-06-18)
|
