Navigation Links
FDA Approves Teflaro for Bacterial Infections
Date:10/29/2010

SILVER SPRING, Md., Oct. 29 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.

CABP is a bacterial infection that develops in the lungs of patients who are exposed to the bacteria in their normal environment, and not in the hospital. ABSSSI is a bacterial infection of skin and skin structures that requires antibiotic treatment and may require surgical treatment.

MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings, according to the Centers for Disease Control and Prevention.

"These are serious and potentially life-threatening infections for which new treatment options are needed," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "FDA is committed to facilitating new antibiotic drug development."

The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.

In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Teflaro was comparable to Vancocin plus Azactam.  

The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.  

Teflaro is marketed by New York City-based Forest Laboratories.

For more information:

FDA: Antibiotics and Antibiotic Resistance

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/AntibioticsandAntibioticResistance/default.htm

Centers for Disease Control and Prevention (CDC): Pneumonia Can Be Prevented

http://www.cdc.gov/features/pneumonia/

CDC: Definition of MRSA

http://www.cdc.gov/mrsa/definition/index.html

CDC: Get Smart: Know When Antibiotics Work

http://www.cdc.gov/getsmart/campaign-materials/online-materials.html

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... PORTLAND, Oregon and PUNE, India , January 16, ... Market Research, titled, "Antioxidants Market by Type - Global Opportunity Analysis and Industry ... and is expected to reach $4,531 million by 2022, registering a CAGR of ... accounted for more than one-third share of the global volume in 2015. ... ...
(Date:1/16/2017)... 2017 Bill is an internationally experienced medical ... and leadership positions with global medical device companies, including Smith & ... of launching new products and building successful businesses in the sector ... Africa and North America . ... Educated at the University ...
(Date:1/16/2017)... Calif. , Jan. 16, 2017  Rigel Pharmaceuticals ... January 3, 2017 and January 16, 2017 the Compensation ... of inducement stock options to purchase an aggregate of ... These awards were granted pursuant to the Rigel Pharmaceuticals, ... to the new employees entering into employment with Rigel, ...
Breaking Medicine Technology:
(Date:1/16/2017)... , ... January 16, 2017 , ... San Francisco dentist, ... Element, the latest in 3-D scanning device which is capable of taking digital impressions ... advances in dentistry, such as CAD CAM restorations , in terms of speed, ...
(Date:1/15/2017)... NY (PRWEB) , ... January 15, 2017 , ... In ... accounts in the United States for the asthma & allergy friendly mark. This certification ... to independently test and identify consumer products to be more suitable for the 60+ ...
(Date:1/15/2017)... ... January 15, 2017 , ... Accreditation ... achieved accreditation for its specialty care services. Albertsons Companies is the largest ... care service for pharmacy patients. , Accreditation by ACHC reflects Albertsons Companies’ dedication ...
(Date:1/15/2017)... ... January 14, 2017 , ... Wondering where to go this Valentine's Day? Well, ... door for a romantic, lobster feast in the comfort of your own home. Lobster ... The dinners will be featured until February 15th, 2017. , Romantic Dinner one is ...
(Date:1/14/2017)... Minneapolis, MN (PRWEB) , ... January 14, 2017 ... ... to present the distinctions among their expanding line of activated charcoal products. With ... emphasizes the importance of categorizing their products according to how they cater to ...
Breaking Medicine News(10 mins):