logo
Share SHARE
FONT-SIZE Plus   Neg

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 RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Volkswagen plans to invest about 22.8 billion euros in its core brand from 2018 to 2022, with main focus on e-mobility and modularization. In a statement on Saturday, the German automaker announced that the investments, as part of the brand's Transform 2025+ strategy, will significantly boost the brand's largest product and technology offensive. Health IQ Insurance Services, a startup focused on providing life insurance for health-conscious individuals, said it has secured $34.6 million in Series C funding, led by Andreessen Horowitz. To date, the company has raised a total of $81 million in funding mostly from its existing investors. General Motors Co. is recalling nearly 49,000 trucks worldwide to fix a fuel tank issue that can increase the risk of a fire. The recall covers Chevrolet Silverado 3500 and GMC Sierra 3500 trucks from the 2011 through 2015 model years, all equipped with dual fuel tanks.
comments powered by Disqus
Follow RTT