Navigation Links
FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Date:3/23/2009

d treatment options for prescribers and patients."

Indication Details:

  1. The new Symbyax TRD indication is for acute treatment of adult patients with major depressive disorder who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode.
  2. Zyprexa, in combination with fluoxetine, is now approved for the acute treatment of TRD in adults.
  3. Symbyax was the first drug approved by the FDA for acute treatment of bipolar depression in adults in 2003. Zyprexa, in combination with fluoxetine, is now approved for the same indication.

With these FDA approvals, clinicians in the United States have the choice to use the single pill option (Symbyax), or the two drugs (Zyprexa and fluoxetine) together, allowing physicians to tailor treatment to each patient's needs. Neither Zyprexa nor fluoxetine are indicated as monotherapy for bipolar depression or TRD.

Additional Label Changes

In addition to the new indications, Lilly has updated the Symbyax and Zyprexa labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia following the FDA's review of clinical trial data that Lilly submitted to the FDA between August 2007 and July 2008. In the course of this review, Lilly provided data from several large databases, including analyses of placebo-controlled data, comparator-controlled data, long-term data and special populations, including antipsychotic-naive patients.

Symbyax and Zyprexa in Combination with Fluoxetine Supportive Study Details for TRD

The data package submitted to the FDA supporting the approval of Symbyax for TRD as well as the approval of Zyprexa in combination with fluoxetine for TRD, included one pivotal trial and data from three supportive trials and one inco
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... 2014 This report studies the ... Handling Systems), Consumables (Tubes), Kits (Isolation, Purification), By ... - Global Forecast to 2018" This market was ... poised to grow at a CAGR of 5.9% ... by 2018. , Browse 98 market data Tables ...
(Date:8/22/2014)... Buying a policy for different life insurance products ... available coverage types by insurers in the U.S. The Quotes ... to the public using its sortable tool at http://quotespros.com/life-insurance.html ... and is expected to promote the discounts and special offerings ... U.S. The system is designed to help an adult locate ...
(Date:8/22/2014)... With the stage set for the ... Expo - which will be held in Boston August ... in its online opinion section, Podium. The op-ed ... co-authored by Steven C. Anderson, IOM, CAE, president & ... the MCPHS University School of Pharmacy – Worcester/Manchester. ...
(Date:8/22/2014)... (PRWEB) August 22, 2014 Japantown Dental ... a new teeth whitening technique. Air polishing is a ... appointments. , Dark teeth can be caused by a ... external stains and internal stains. External stains include coffee, ... be caused by certain medications, such as tetracycline, and ...
(Date:8/22/2014)... FL (PRWEB) August 22, 2014 Millennium Treatment ... marijuana, resulting in a high level of drug use among ... ages fight against drug addiction and work to minimize drug ... levels of alcohol and drug addiction in history. According to ... an estimated 23.9 million Americans aged 12 or older—or 9.2 ...
Breaking Medicine News(10 mins):Health News:Sample Preparation Market by Product and Application Worth $5,672 Million by 2018 - New Research Report by MarketsandMarkets 2Health News:Sample Preparation Market by Product and Application Worth $5,672 Million by 2018 - New Research Report by MarketsandMarkets 3Health News:Sample Preparation Market by Product and Application Worth $5,672 Million by 2018 - New Research Report by MarketsandMarkets 4Health News:Principal Life Insurance Policies Now Quoted for Adults at Insurance Website Online 2Health News:The Boston Globe Publishes Value of Pharmacy Op-ed as NACDS Total Store Expo Begins 2Health News:The Boston Globe Publishes Value of Pharmacy Op-ed as NACDS Total Store Expo Begins 3Health News:Japantown Dental Introduces Air Polishing 2Health News:Millennium Treatment Group Sees Increase in Marijuana Use Among Youth 2
... ... for health supplements, customers who want to reduce or reverse the signs of aging. ... ... -- Increased positive coverage by respected media outlets has helped clear up many of ...
... ... ... -- CMS Watch announced today that it has changed its name to The Real ... , , ,“The new name better reflects what we,ve been doing for nearly a decade: ...
... ... ... ... ...
... , ... ... ... ...
... ... ... ... ...
... Scientists from Sydney,s Garvan Institute of Medical Research have ... Biology , describing gene expression in a prostate cancer ... we could ever have imagined, even five years ago. ... cancer cell ,epigenome, (biochemical processes that target DNA and ...
Cached Medicine News:Health News:Sytropin HGH Shows Promising Anti-Aging Results 2Health News:CMS Watch Changes Name to The Real Story Group 2Health News:CMS Watch Changes Name to The Real Story Group 3Health News:Diabetics Twice as Likely to Have Hearing Loss; Massachusetts HearUSA Centers to Offer Free Hearing Screening and Diabetes Video in March 2Health News:Diabetics Twice as Likely to Have Hearing Loss; Massachusetts HearUSA Centers to Offer Free Hearing Screening and Diabetes Video in March 3Health News:Diabetics Twice as Likely to Have Hearing Loss; Massachusetts HearUSA Centers to Offer Free Hearing Screening and Diabetes Video in March 4Health News:Diabetics Twice as Likely to Have Hearing Loss; Massachusetts HearUSA Centers to Offer Free Hearing Screening and Diabetes Video in March 5Health News:ChildCare Education Institute Supports the First Lady's Efforts to Reduce Childhood Obesity 2Health News:ChildCare Education Institute Supports the First Lady's Efforts to Reduce Childhood Obesity 3Health News:ChildCare Education Institute Supports the First Lady's Efforts to Reduce Childhood Obesity 4Health News:ChildCare Education Institute Supports the First Lady's Efforts to Reduce Childhood Obesity 5Health News:Global Hospitals and Healthcare Suppliers Focus on Cutting Costs and Improving Quality at 2010 GHX Supply Chain Summit 2Health News:Global Hospitals and Healthcare Suppliers Focus on Cutting Costs and Improving Quality at 2010 GHX Supply Chain Summit 3Health News:Global Hospitals and Healthcare Suppliers Focus on Cutting Costs and Improving Quality at 2010 GHX Supply Chain Summit 4Health News:Global Hospitals and Healthcare Suppliers Focus on Cutting Costs and Improving Quality at 2010 GHX Supply Chain Summit 5Health News:What it might take to unravel the 'lean mean machine' that is cancer 2Health News:What it might take to unravel the 'lean mean machine' that is cancer 3
(Date:8/22/2014)... CHAPEL HILL, N.C. , Aug. 22, 2014 /PRNewswire/ ... pharmaceutical organizations and thought leaders in the healthcare sector. ... to evolve, the iPad is changing how Medical Science ... MSLs are using the tablet to ... physicians but also to better coordinate thought leader interactions ...
(Date:8/22/2014)... , August 22, 2014 ... Markets ( http://www.researchandmarkets.com/research/x34qgv/global_laboratory ) has announced the addition ... 2014-2018"  report to their offering.  ... is an essential instrument for any modern ... precise weighing of materials. It can be ...
(Date:8/22/2014)... Research and Markets ( ... the  "Global Operating Room Equipment Market 2014-2018" ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ,An operating room is ... a healthcare facility used to perform surgical ... equipment, which ensures patient care and enhanced ...
Breaking Medicine Technology:iPads Enhancing Medical Science Liaison Interactions with Thought Leaders, New Study Shows 2Global Laboratory Electronic Balance Market 2014-2018: Key Vendors are A&D Company, Mettler-Toledo, Sartorius and Thermo Fisher 2Global Operating Room Equipment Market 2014-2018: Key Vendors are Getinge, STERIS, Stykron and TRUMPF Medical Systems 2
... 2011 The Myth that physicians workload lessens ... with the New Year quickly approaching physicians are preparing for ... RNCOS depicts Healthcare IT spending by physicians and other healthcare ... this year, with most of it attributed to electronic health ...
... Therapeutics, Inc. (PTC) today announced the receipt of ... from the Wellcome Trust to support the development ... by multidrug-resistant (MDR) Gram-negative bacteria.  PTC previously received ... Trust to support its BMI1 oncology program. ...
Cached Medicine Technology:Medicalbillersandcoders.com Puts its Service Offers to Physicians Who Strive to Streamline Their Practice This Holiday Season! 2Medicalbillersandcoders.com Puts its Service Offers to Physicians Who Strive to Streamline Their Practice This Holiday Season! 3Medicalbillersandcoders.com Puts its Service Offers to Physicians Who Strive to Streamline Their Practice This Holiday Season! 4PTC Therapeutics' Antibacterial Program Receives $5 Million Award from the Wellcome Trust 2
... powder reagent once reconstituted offers the ... liquid stability to help maximize laboratory ... quick result turnaround time. The proprietary ... reagent provides a long shelf life ...
... AST (GOT) powder reagent once reconstituted offers ... liquid stability to help maximize laboratory productivity, ... turnaround time. The patented technology of the ... long shelf life and stability once reconstituted ...
LCD chart display...
... forceps are extremely delicate and if repairs ... they can easily be damaged beyond repair ... endoscopes. , On the other hand, with ... can have a virtually indefinite lifespan. The ...
Medicine Products: