logo
Plus   Neg
Share
Email

Salix, Progenics Announce FDA Extension Of RELISTOR SNDA Goal Date To July 27

Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration, or FDA, has extended the Prescription Drug User Fee Act goal date for the Agency's review of the Supplemental New Drug Application, or sNDA, for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.

The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the April 27, 2012 goal date by the standard extension period of three months. The extended user fee goal date is July 27, 2012. The extension requested no additional studies.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Walmart is ditching its dress code policy and is testing a new dress code that will allows "associates" to wear blue denim and shirts of any solid color. The updated dress coded guidelines now allow employees to wear blue "jeggings" and blue jeans and shirts of any solid color, according to a Walmart... Canadian investment firm Fairfax Financial Holdings Ltd. has submitted a "stalking horse" bid worth C$300 million, or $237 million, for the Canadian unit of Toys "R" Us, according to court documents. A stalking horse bid is an initial bid on the assets of a bankrupt company. The bankrupt company will choose an entity from a pool of bidders who will make the first bid on its assets. The car rental market in the U.S. is consolidating as large car rental companies are buying smaller, local companies to expand their portfolio of premium and value brands. The key players in the U.S. market include Enterprise Holdings, Hertz Global Holding and Avis Budget Group. Let's take a look at some of the best and worst car rental companies in the U.S.
Follow RTT