Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee.
In November, 2008, the FDA filed the Company's NDA for cethromycin and established a target Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) action date for the cethromycin NDA of July 31, 2009. Further details pertaining to the AIDAC meeting will be provided by Advanced Life Sciences upon receipt of additional information from FDA.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. For more information, please visit us on the web at http://www.advancedlifesciences.com/.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. , dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
CONTACT: Joe Camp of Advanced Life Sciences Holdings, Inc., +1-630-754-4352, firstname.lastname@example.org
Web Site: http://www.advancedlifesciences.com/
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|Date:||Feb 27, 2009|
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