Navigation Links
Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza(TM) (cethromycin)

CHICAGO, May 29 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the June 2, 2009 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. At the meeting, the AIDAC will review and discuss Advanced Life Sciences' New Drug Application (NDA) for Restanza(TM) (cethromycin) in the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).


Briefing documents from FDA and Advanced Life Sciences can be found on FDA's website at

Advanced Life Sciences is planning a conference call for the morning of Wednesday, June 3, to discuss the results of the June 2nd AIDAC Meeting. Additional call information will be forthcoming.

About Restanza(TM)

Restanza(TM) is a second generation ketolide antibiotic that is administered once a day through oral dosing. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin-, macrolide-, and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance, may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CAP, Restanza(TM) is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza(TM) as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.

About Community Acquired Pneumonia (CAP)

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

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

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.

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. More Living Longer With Advanced Colon Cancer
2. Advanced Technologies Pump Growth Into European Cardiac Rhythm Management Market, Affirms Frost & Sullivan
3. Advanced Prostate Cancer Deadlier in Younger Men
4. Younger men with advanced prostate cancer have shorter survival times
5. African-American women with advanced breast cancer often forego vital treatment
6. Medivation Announces Upcoming Presentation of New MDV3100 Data in Patients With Advanced Prostate Cancer at 45th American Society of Clinical Oncology Annual Meeting
7. Nexavar Approved in Japan for the Treatment of Advanced Liver Cancer
8. SETO Holdings, Inc. Signs Agreement to Acquire Advanced Hearing Centers, Inc. and Will Dispose of All Existing Business; New Management to be Installed
9. Frost & Sullivan: Clinical and Cost Benefits to Promote Uptake of Advanced Wound Management Technologies Across Europe
10. Misonix Announces Attendance at 22nd Annual Symposium on Advanced Wound Care
11. Hyperferritinemia is another surrogate marker of advanced liver disease
Post Your Comments:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... San Diego, CA (PRWEB) , ... June 24, 2016 , ... ... up with the American Cancer Society and the Road To Recovery® program to drive ... care to seniors and other adults to ensure the highest quality of life and ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
Breaking Medicine Technology: