Factive

This page contains recent news articles, when available, and an overview of Factive but does not offer medical advice. You should contact your physician with regard to any health issues or concerns.


Overview:

Factive
(when available)

Pharmacology and use:
Gemifloxacin is a quinolone/fluoroquinolone antibiotic. Gemifloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gemifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. For the treatment of Bacterial infection caused by susceptible strains such as S.pneumoniae, H.influenzae, H.parainfluenzae, or M.catarrhalis, S.pneumoniae (including multi-drug resistant strains [MDRSP]), M.pneumoniae, C.pneumoniae, or K.pneumoniae.

Mechanism Of Action:
The bactericidal action of Gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

News Articles on Gemifloxacin

FDA requests warnings on fluoroquinolone antimicrobial drugs  -  07 Aug 2008
The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive Chiropractic Economics,

Oscient Pharmaceuticals Reports Second Quarter 2008 Financial Results  -  Aug 1, 2008
This compares to $15.9 million in total revenues recorded in the second quarter of 2007, with $14.1 million from ANTARA and $1.8 million from FACTIVE. MarketWatch

FDA tells Oscient to revise Factive label, warnings  -  Jul 8, 2008
Oscient Pharmaceuticals Corp. has received notice from federal regulators to revise the usage and warning labels of its blockbuster Factive pneumonia and Bizjournals.com,

Oscient Pharma Posts Wider Loss In Q2; Cuts FY08 Revenue Outlook  -  Aug 1, 2008
Revenue for the quarter included $18.4 million in revenue from the cardiovascular drug ANTARA and $1.9 million in revenue from the antibiotic FACTIVE RTT News,

FDA Issues Antibiotic Warning  -  Jul 30, 2008
The antibiotics to watch for include: Cipro, Cipro XR, Proquin XR, Factive, Levaquin Avelox, Noroxin and Floxin. The Anti-Aging Bottom Line: More forceful Stop Aging Now,

FDA Warns Of Tendon-Rupturing Antibiotics  -  Jul 17, 2008
Drugs in this group include Cipro, Levaquin, Avelox, Oscient, Factive, Proquin XR, Floxin Noroxin. Ruptures associated with the drug have included the The Consumerist,

Europe's Antibiotic Warnings  -  Jul 30, 2008
Affected fluoroquinolone drugs include: Cipro, Cipro XR and Proquin XR, Factive, Levaquin, Avelox, Noroxin and Floxin, and generic ofloxacin. Pharmaceutical Technology Magazine,

Oscient Pharmaceuticals Promotes Mark A. Glickman to Senior Vice ...  -  Jul 31, 2008
FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. PharmaLive.com (press release),

Some Antibiotics Could Damage Tendons, FDA Says  -  Jul 14, 2008
...s Factive, Depomed Inc.'s Proquin XR, and Ortho-McNeil's (a Johnson & Johnson subsidiary) Levaquin and Floxin. Cipro and Levaquin, two leading drugs Evening Bulletin,

LegalView Blog Announces Recruitment of Mesothelioma Victims for ...  -  Jul 13, 2008
Denver, CO (PRWEB) July 12, 2008 -- LegalView, the most comprehensive legal resource available on the Web, released details of a newly advertised clinical PR-USA.net (press release),

Oscient Pharmaceuticals Lowers Guidance Inline with Estimates  -  Aug 1, 2008
...(NASDAQ: OSCI | Quote | Chart | News | PowerRating) said it now expects 2008 revenue of $92.0 million to $99.0 million from ANTARA and FACTIVE. Trading Markets (press release),

Exigen poner advertencia en antibióticos  -  Jul 9, 2008
Las medicinas que forman parte de esta acción son Cipro y su genérico ciprofloxacino, Cipro XR, Proquin XR, Factive, Levaquin, Avelox, Noroxin y Floxin y su Univisión

FDAå°?Cipro等抗生素發出é‡?大緊急警告  -  Jul 14, 2008
FDA因此下令生產Cipro�Cipro XR�Proquin XR�Factive 中央日報,

美 ‘플루오로퀴놀론’ 블랙박스 경고  -  Jul 8, 2008
...플루오로퀴놀론 계열 항�제로는 ‘시프로’(Cipro, ciprofloxacin), ‘팩티브’(Factive, gemifloxacin), ‘레바퀸’(Levaquin, levofloxacin), ‘아벨�스’(Avelox, 디지틀보사,

美FDA警告抗生素伤害肌腱  -  Jul 13, 2008
...厂出产的Cipro与Avelox�Oscient Pharmaceuticals的Factive 大纪元

FDA alerta sobre risco de tendinites e rupturas de tendão devido a ...  -  Jul 10, 2008
Os avisos devem afectar o Cipro (ciprofloxacina) eo Avelox (moxifloxacina), da Bayer AG, o Factive (mesilato de gemifloxacino), da Oscient Pharmaceuticals Farmacia,

플로로퀴놀론계 í•­ìƒ?ì œ, 블랙 박스 경고 추가  -  Jul 8, 2008
...�번 경고 조치는 씨프로 외� 바�엘� ‘아벨�스(Avelox)’, LG� ‘팩티브(Factive)’, J&J� '레바퀸(Levaquin)’과 ‘플�신(Floxin)’ 그리고 머�� ‘노� 메디게�트뉴스,

×?זהרה חמורה של ×”-FDA ל×?נטיביוטיקה  -  Jul 8, 2008
...(Proquin XR), לווקוין (Levaquin), פלוקסין (Floxin), נורוקסין (Noroxin), ×?בלוקס (Avelox), פקטיב (Factive). על-פי הערכות ×”×?רגון, קרעי×? ספונטניי×? בגידי×? Nfc חדשות מחלקה ר×?שונה,

FDA ordnet schärfere Warnhinweise bei Bayer-Antibiotika an  -  Jul 8, 2008
T: Kurs) sowie Factive von Oscient Pharmaceuticals(OSCI.O: Kurs) betroffen. Bayer erwirtschaftete im vergangenen Jahr mit dem Antibiotikum Cipro einen Reuters Deutschland,

퀴놀론계 í•­ê· ì œ, “아킬레스건 파열 조심â€? 블랙박스 경고  -  Jul 9, 2008
...주로 아킬레스 건 파열�며 �러한 경고 조치를 취한 약물� ciprofloxacin(Cipro, Cipro XR � Proquin XR 등), gemifloxacin(Factive), levofloxacin(Levaquin), 메디�뉴스,

抗生素å?¯è‡´è‚Œè…±æ–·è£‚  -  Jul 9, 2008
...�明報專訊】美國食��藥物管�局( FDA)昨建議,藥廠應在抗生素Cipro的包�上加警告字�,指有關抗生素�能會引致肌腱斷裂。當局指肌腱斷裂常見于�動創傷,但該種 新浪北美,

Appointment of Interim Consultant CMO  -  Jun 20, 2008
...as President of Genesoft, Dr. Patou was instrumental in applying for and obtaining FDA approval of the company's lead product, FACTIVE® tablets. PharmaLive.com (press release),

FDA To Increase Scrutiny Of Drug Risks With Sentinel System  -  Jun 17, 2008
For example, if the FDA would like to know how often antibiotics like Cipro and Factive cause ruptured tendons, with Sentinel, Medicare officials could be InjuryBoard.com,

The Top 60: echo Torre Lazur  -  Jun 30, 2008
The firm also won assignments for Oscient's Antara lipid drug and Factive antibiotic, along with an Axcan Pharma pancreatic enzyme deficiency drug. Medical Marketing and Media,

BUYINS.NET: FVRL, GNVC, HYDG, OESX, OSCI, PHHM Have Also Been ...  -  Jun 20, 2008
...and FACTIVE (gemifloxacin mesylate) tablets, a fluoroquinolone antibiotic used for the treatment of acute bacterial exacerbations of chronic bronchitis Trading Markets (press release),

Analyst Comments: Vimpel, Magna, NewAlliance, Omnicom, Oscient ...  -  Jun 19, 2008
Corporation's (OSCI) sales force has done a commendable job in driving growth for its two products, cholesterol drug Antara and antibiotic Factive. istockAnalyst.com,

Regulatory Filing for FACTIVE Tablets Submitted in Europe  -  May 7, 2008
..."Menarini's pursuit of marketing approval for FACTIVE in Europe is an important step in our commercialization plan for FACTIVE in our licensed territories," Centre Daily Times,

FDA to Expand Scrutiny of Risks From Drugs After They’re Approved ...  -  May 22, 2008
For instance, Dr. Woodcock said she would like to know how often antibiotics like Cipro and Factive cause ruptured tendons. The agency has received enough New York Times,

OSCI: CEO Discusses Q1 Results; Sees Revenue Growth from ANTARA(R)  -  May 7, 2008
The Company reiterated that it expects $96-103 million in revenue for fiscal year 2008 from ANTARA(R) and FACTIVE(R), with approximately three-quarters of Trading Markets (press release),

Market Report -- In Play (WIRES)  -  May 7, 2008
On The Wires Oscient Pharmaceuticals' (OSCI) commercialization partner for FACTIVE tablets, Menarini Group, has submitted a regulatory filing seeking MSN Money

Zacks Bull and Bear of the Day Highlights: NCR Corp., Ness ...  -  May 9, 2008
Oscient currently has two marketed products in its portfolio Antara and Factive. We believe the Oscient sales force has done a commendable job in driving Business Wire (press release),

Zacks Bull and Bear of the Day Highlights: NCR Corp., Ness ...  -  May 9, 2008
Oscient currently has two marketed products in its portfolio Antara and Factive. We believe the Oscient sales force has done a commendable job in driving PR-Inside.com (Pressemitteilung),

UPDATE 1-Oscient Pharma shrs fall on weak Q1 revenue view  -  Apr 16, 2008
..."While quarterly revenue fluctuates due to the timing of shipments and wholesaler buying patterns, as well as the seasonality of Factive, we remain on track Reuters

Oscient Pharmaceuticals sinks on 1Q revenue outlook  -  Apr 16, 2008
Oscient Pharmaceuticals Corp. backed its full-year forecast of $96 million to $103 million from sales of Antara and Factive, a treatment for pneumonia and CNNMoney.com

Cash Systems Granted New Contract From Fantasy Springs Resort ...  -  Apr 16, 2008
Also, the company reiterated guidance of $96 million -$103 million in revenues from Antara and Factive tablets in 2008 and $28 million - $30 million in net RTT News,

BUYINS.NET: COMV, FRPT, MCHX, OSCI, STXS, TBSI Have Also Been On ...  -  Apr 11, 2008
...and FACTIVE (gemifloxacin mesylate) tablets, a fluoroquinolone antibiotic used for the treatment of acute bacterial exacerbations of chronic bronchitis Manufacturing Business Technology,

Oscient Pharmaceuticals Provides Preliminary Revenue Results for ...  -  Apr 16, 2008
..."While quarterly revenues fluctuate due to the timing of shipments and wholesaler buying patterns, as well as the seasonality of FACTIVE, we remain on track PharmaLive.com (press release),

Streetinvesting.com: Progressive Following on Oscient ...  -  Apr 16, 2008
FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Trading Markets (press release),

Market Report -- In Play (OSCI)  -  Apr 16, 2008
Co says "quarterly revenues fluctuate due to the timing of shipments and wholesaler buying patterns, as well as the seasonality of FACTIVE. MSN Money

Pre-Open Movers 4/16: POZEN (POZN) Surges On FDA Approval; Movado ...  -  Apr 16, 2008
The Company reiterates its previously announced guidance of $96-$103 million in revenues from ANTARA and FACTIVE tablets in 2008 and $28-$30 million in net StreetInsider.com (subscription),

Oscient Pharmaceuticals to Participate in the Roth Capital ...  -  Feb 14, 2008
FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Centre Daily Times,

Canceled Panel, Delays Could Signal Trouble for Telavancin  -  Mar 7, 2008
...s Factive (gemifloxacin) were met with rejection in 2006 in acute bacterial sinusitis as the FDA started seeking more conclusive efficacy data beyond the BioWorld Online,

BUYINS.NET: HDP, MEG, CTCT, GRIN, IFNY, OSCI Have Been Added To ...  -  Mar 4, 2008
...and FACTIVE (gemifloxacin mesylate) tablets, a fluoroquinolone antibiotic used for the treatment of acute bacterial exacerbations of chronic bronchitis Trading Markets (press release),

Oscient Pharmaceuticals Records 2007 Revenues of $80 Million ...  -  06 Feb 2008
Market share: For the fourth quarter of 2007, among all prescriptions for fluoroquinolones written to treat respiratory tract infections, FACTIVE had FOXBusiness

Webcast Alert: Oscient Pharmaceuticals Announces Date for Release ...  -  Feb 1, 2008
FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. CNNMoney.com

Oscient Pharmaceuticals Provides Preliminary Revenue Results for ...  -  Jan 14, 2008
In 2007, approximately $59 million in revenue was derived from ANTARA and approximately $21 million in revenues from FACTIVE. The Company expects its total StreetInsider.com (subscription),

Market Report -- In Play (OSCI)  -  Jan 14, 2008
...revenue of approximately $25 mln vs First Call consensus of $25.1 mln (2 ests), with $19 mln from Antara capsules and $6 mln related to Factive tablets. MSN Money

Type of antibiotic linked to tendon ruptures  -  Jan 9, 2008
Fluoroquinolone antibiotics are prescribed for bacterial infections and include ciprofloxacin (Cipro), gatifloxacin, gemifloxacin (Factive), Biloxi Sun Herald,

The SI Report: Market Review for Oscient Pharmaceuticals Corporation  -  Feb 4, 2008
FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Trading Markets (press release),

Sherpa 101: How to Use Digg to Go Viral - 10 Strategies to Making ...  -  Jan 8, 2008
I’ve had one with 2000 or 3000 minimum,� says Dean Hunt, Buzz Marketer, MidasCode Ltd. Cameron Olthuis, CEO, Factive Media, says he gets articles onto the MarketingSherpa.com (subscription),

Oscient Pharmaceuticals Reports Financial Results for Third ...  -  Oct 31, 2007
During the third quarter of 2007, the Company recorded approximately $12.8 million in revenue from ANTARA and $2.8 million in revenues related to FACTIVE(R) PharmaLive.com (press release),

Oscient Pharmaceuticals to Participate in the JMP Securities ...  -  Nov 6, 2007
FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and Trading Markets (press release),

Pinker examines language, 'facts' and truths in 'The Stuff of Thought'  -  Nov 3, 2007
..."Learn is what linguists call a factive verb; it entails that the belief attributed to the subject is true. In that way, it is like the verb know and unlike The Plain Dealer - cleveland.com,

Linkbait Back to the Future  -  Oct 24, 2007
The panelists, Rebecca Kelley of seomoz, Brent Csutoras of brentcsutoras.com, and Cameron Olthuis of Factive Media, covered all angles of linkbait, AffiliateTip.com,

Oscient Pharmaceuticals Provides Preliminary Revenue Results for ...  -  Oct 10, 2007
In the third quarter of 2007, more than 41500 prescriptions for FACTIVE were dispensed, compared to 46000 prescriptions dispensed during the second quarter PharmaLive.com (press release),

Oscient issues upbeat forecast  -  Oct 10, 2007
Oscient said it expects to record about $12.5 million in revenue from Antara and about $3 million from Factive, a treatment for acute bacterial Boston Globe,

UPDATE 1-Oscient Pharma sees Q3 revenue below Wall Street view  -  Oct 10, 2007
Oscient said it expects cardiovascular drug Antara to add about $12.5 million in revenue and its antibiotic Factive to contribute about $3 million for the Reuters

Oscient Pharmaceuticals Corporation reports preliminary revenue ...  -  Oct 11, 2007
The company expects to record approximately USD12.5m in revenue from ANTARA and approximately USD3m in revenues from FACTIVE during the third quarter of Trading Markets (press release),

Market Report -- In Play (OSCI)  -  Oct 10, 2007
Co expects to record approx $12.5 mln in revs from Antara and approx $3 mln in revs from Factive. For Q3, Antara revs were reduced by a $1.7 mln charge MSN Money

Oscient Pharmaceuticals to Participate in the Natixis Bleichroeder ...  -  Oct 1, 2007
FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and Live-PR.com (Pressemitteilung),

Words to get your neurons firing  -  Sep 22, 2007
...where, how and why - Rudyard Kipling's "Rule of Six" - does provide an opportunity of introducing readers to the linguistic concept of a "factive verb," Globe and Mail,

Oscient Pharmaceuticals Receives Notice of Allowance for ...  -  07 Sep 2007
FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic FDA-approved for the treatment of acute bacterial exacerbations of chronic bronchitis and PharmaLive.com (press release),

KORUS FTA good medicine for local drug industry: health official  -  Sep 3, 2007
A local company produced Korea's first new drug, “Sunpla,� in 1999 and in 2003, "Factive," a chemically synthesized drug, was born, which received sales Korea.net,

Oscient Pharmaceuticals Names Aaron D. Berg Vice President of ...  -  Aug 23, 2007
FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and Genetic Engineering News (press release),

Photosensitive medicines listed  -  Aug 23, 2007
...dapsone demeclocycline (Declomycin); doxycycline (Vibramycin); ethionamide (Trecator-SC); flucytosine (Ancobon); gemifloxacin (Factive); Biloxi Sun Herald,

Oscient Pharmaceuticals Reports Financial Results for Second ...  -  Aug 2, 2007
PharmaLive.com (press release),This decrease reflects completion of the FACTIVE post-marketing study during the first quarter of 2007, nearly a year ahead of schedule.

Average reductions currently few that elicits entail.  -  Jul 10, 2007
LIVE-Wintersport.com,Excellent reviews jury verdict factive were placed assumed. The symptoms surgery for women were of use cold. Other patients centers per errors were hospital

Brand Names/Synonyms:
Factive is also known by the following brand names and/or synonymsFactive; Gemifloxacin; Gemifloxacin Mesilate; Gemifloxacin [Inn]

Drug Category:
Factive is categorized under the following by the FDA: Anti-bacterial Agents; ATC:J01MA15

Dosage Forms:
TABLET

Absorption:
Gemifloxacin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of the 320 mg tablet averaged approximately 71% (95% CI 60%-84%).

Interactions:
-->Interactions for Gemifloxacin:

Administration of repeat doses of FACTIVE had no effect on the repeat dose pharmacokinetics of theophylline, digoxin or an ethinylestradiol/levonorgestrol oral contraceptive product in healthy subjects.

Concomitant administration of FACTIVE and calcium carbonate, cimetidine, omeprazole, or an estrogen/progesterone oral contraceptive produced minor changes in the pharmacokinetics of gemifloxacin, which were considered to be without clinical significance.

Concomitant administration of FACTIVE with probenecid resulted in a 45% increase in systemic exposure to gemifloxacin.

FACTIVE had no significant effect on the anticoagulant effect of warfarin in healthy subjects on stable warfarin therapy. However, because some quinolones have been reported to enhance the anticoagulant effects of warfarin or its derivatives in patients, the prothrombin time or other suitable coagulation test should be closely monitored if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives.

Quinolones form chelates with alkaline earth and transition metals. The absorption of oral gemifloxacin is significantly reduced by the concomitant administration of an antacid containing aluminum and magnesium. Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other metal cations, or Videx (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be taken within 2 hours of FACTIVE.





Chemical IUPAC Name:
1-acetyloxycyclohexane-1-carboxylicacid

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