Restanza
Generic name: cethromycin
Treatment for: Pneumonia
Notice of Cethromycin Review by FDA Advisory Committee
Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee
CHICAGO, February 27, 2009 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on June 2, 2009, and will discuss the New Drug Application (NDA) for cethromycin, a new once-a-day oral antibiotic for the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).
In November, 2008, the FDA filed the Company's NDA for cethromycin and established a target Prescription Drug User Fee Act (PDUFA) 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.
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.
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 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 technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and 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.
Posted: February 2009
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- Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza (Cethromycin) in Community Acquired Pneumonia - August 6, 2009
- Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin) - June 3, 2009
- Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin) - May 29, 2009
- Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia - December 3, 2008
- Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia - October 1, 2008
- Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin - April 10, 2008
Restanza (cethromycin) FDA Approval History
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