Join        Login             Stock Quote

Jazz Pharmaceuticals (JAZZ) Retreats after FDA Denies Citizens Petition

 November 14, 2012 10:53 AM

(By Balachander) Jazz Pharmaceuticals Plc (NASDAQ: JAZZ) shares retreated in early Wednesday trade after after the U.S. health regulators denied its Citizens Petition.

The Dublin-based company had in May submitted a Citizen Petition to the U.S. Food & Drug Administration addressing the legal and scientific bases for requiring in vivo bioequivalence studies for generic formulations of Xyrem (sodium oxybate) oral solution.

XYREM is a FDA-approved medication for the treatment of excessive (too much) daytime sleepiness and the treatment of cataplexy (weak or paralyzed muscles), both in patients with narcolepsy.

[Related -What The Market Wants: ISM Leads Market Down Bearish Path]

Jazz requsted the FDA publish bioequivalence requirements specifying whether in vitro or in vivo bioequivalence studies, or both, are required for abbreviated new drug applications (ANDAs) referencing Xyrem

The company also requested that the FDA not accept any generic versions for review until the FDA has published the bioequivalence requirements.

Further, Jazz disclosed that the FDA response did not address its Citizen Petition filed on July 10. The petition asks the FDA to rescind the acceptance of any previously-accepted ANDA referencing Xyrem, including the ANDA filed by Roxane Laboratories Inc.

The company believes that the FDA's premature acceptance of Roxane's ANDA caused the thirty-month stay under the Hatch-Waxman Act and the related patent litigation between the parties to begin prematurely in a manner contrary to the law, a regulatory filing made in July showed.

[Related -Jazz Pharma (JAZZ) Initiated At 'Buy' By Brean Murray, $81 PT]

The stock, which has been trading in a 52-week range of $34.39 to $60.00, shed 3.76 percent to trade at $50.94 on Wednesday.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageAvoid Amazon Before It Disappoints Again

Heading into the 2013 holiday season, the Amazon.com, Inc. (Nasdaq: AMZN) juggernaut could not be read on...

article image4 Most Hated Dividend Stocks You Should Know Before You Invest

Shorting stocks is always risky for investors. But it can be a sure way to avoid burning cash when a read on...

article imageAnother Long Uptrend in Stocks is Unlikely to Occur in the Near Future

The last golden cross in S&P 500 occurred on January 31, 2012. The 50-dma has stayed above the 200-dma for read on...

article imageThe $7 Billion Reason To Short Retail

After nine months of fruitless negotiations, the International Longshore and Warehouse Union and the read on...

Popular Articles

Daily Sector Scan
Partner Center

Related Articles:

5 Favorites: PEG Values
More Articles on: Medical , Europe

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.