Daily Stock Setups

Salix announces FDA complete response letter for Metozolv ODT

Posted on: Fri, 27 Feb 2009 11:37:00 EST

Symbols: SLXP

Are you looking to increase your ETF knowledge?

Feb 27, 2009 (Datamonitor via COMTEX) --
SLXP | Quote | Chart | News | PowerRating -- Salix Pharmaceuticals, a specialty pharmaceutical company, has announced that Wilmington Pharmaceuticals has received a complete response letter from the FDA for its new drug application for Metozolv orally disintegrating tablets, 5mg and 10mg.

Also, in a separate action, the FDA issued a class-wide requirement for all manufacturers of metoclopramide in the US to provide a risk evaluation and mitigation strategy (REMS) for their products. As a consequence of this action, the FDA indicated in complete response letter that a REMS for Metozolv orally disintegrating tablets (ODT) is required prior to approval of the new drug application.

Bill Forbes, chief development officer of Salix, said: "In regard to the metoclopramide class-wide requirement for a REMS, the issue involves an adverse event of metoclopramide known as tardive dyskinesia, that is widely-known among healthcare professionals and is well-documented in the literature and current labeling of metoclopramide products.

"The decision of the FDA to elevate the warnings surrounding tardive dyskinesia to a boxed warning on the package insert requires the issuance of a medication guide that will be distributed to patients and healthcare professionals to better educate as to the proper use of metoclopramide. We intend to submit this newly-required item by mid March 2009 and will work with the FDA to expedite the approval of Metozolv ODT."

http://www.datamonitor.com

Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall 
not be liable for errors or delays in the content, or for any actions 
taken in reliance thereon

For full details on Salix Pharmaceuticals Ltd (SLXP) SLXP. Salix Pharmaceuticals Ltd (SLXP) has Short Term PowerRatings at TradingMarkets. Details on Salix Pharmaceuticals Ltd (SLXP) Short Term PowerRatings is available at This Link.

More News: Market Updates | Stock Alerts | All Trading News

Disclaimer:

The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.

It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.

HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.

The Connors Group, Inc.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302

All analyst commentary provided on TradingMarkets.com is provided for educational purposes only. The analysts and employees or affiliates of TradingMarkets.com may hold positions in the stocks or industries discussed here. This information is NOT a recommendation or solicitation to buy or sell any securities. Your use of this and all information contained on TradingMarkets.com is governed by the Terms and Conditions of Use. Please click the link to view those terms. Follow this link to read our Editorial Policy.