Navigation Links
Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
Date:7/28/2008

ROCKVILLE, Md., July 28 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.

The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day in the 3101 study for which the company reported results in December, 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon(R), Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day in a prior study. However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies. The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa(R), Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound's efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24 mg/day.

"We are disappointed by this response, but will meet with the FDA to discuss this decision further," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

Vanda has put on hold all iloperidone-related activities pending further review.

As of June 30, 2008, Vanda's cash, cash equivalents, and marketable securities totaled approximately $65.6
'/>"/>

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Vanda Pharmaceuticals to Present at the FBR Capital Markets 12th Annual Spring Investor Conference
2. Vanda Pharmaceuticals Announces that it No Longer Intends to Offer Convertible Senior Notes
3. Vanda Pharmaceuticals VSF-173 Excessive Sleepiness Phase II Clinical Trial Suggests Wake-Promoting Properties
4. Vanda Pharmaceuticals to Announce Third Quarter 2007 Financial Results on November 8, 2007
5. Vanda Pharmaceuticals to Present New Data on Iloperidone at the 2007 American Society of Human Genetics Annual Meeting
6. Vanda Pharmaceuticals to Present at Natixis Bleichroeders Hidden Gems Conference
7. Sagent Pharmaceuticals Launches Amiodarone HCl Injection, USP
8. New Natural Product from Zurich Pharmaceuticals Downs Appetite
9. AUDIO from Medialink and Duramed Pharmaceuticals: Not Your Mothers Menopause
10. Genesis Pharmaceuticals Announces New Board Member and Forms Committees
11. Sound Pharmaceuticals Receives Additional DoD Funding for Its Hearing Regeneration Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... (PRWEB) August 21, 2014 A new ... a 63% increase in disability associated with speech problems ... a more than 15% increase in disability associated with ... intervention for rising numbers of children who are experiencing ... (ASHA). , On a broader level, the ...
(Date:8/21/2014)... 21, 2014 Researchers in the United Kingdom have ... quickly and accurately diagnose a number of rare diseases ... published online today in Ophthalmology , the ... a single test, doctors were able to tailor care ... reducing the time and money spent on diagnosis and ...
(Date:8/21/2014)... The report "Industrial Flue Gas Treatment ... (FGD, DeNOx, Particulate Control, Mercury Control) by Application ... Others) - Global Trends & Forecasts to 2019" ... treatment systems & services market with analysis and ... of value. The industrial flue gas treatment systems ...
(Date:8/21/2014)... Revista, a one-stop source for healthcare ... is “on a roll.” Today, the Annapolis-based company ... Southeast, Mid-Atlantic and Midwest areas of the country ... available, comprehensive medical property database tracking these regions. ... including existing and recently added, is 34,549. This ...
(Date:8/21/2014)... Steven Reinberg HealthDay Reporter ... of U.S. teens using sunscreen dropped nearly 12 percent in ... same time period, the number of teens using indoor tanning ... sunscreen increase the risk of skin cancers, including deadly melanomas, ... the overall percentage of teens who reported wearing sunscreen, from ...
Breaking Medicine News(10 mins):Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 2Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 3Health News:New DNA test for diagnosing diseases linked to childhood blindness 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 3Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 4Health News:Revista Medical Property Data Now Available for the Mid-Atlantic, Southeast and Midwest Regions 2Health News:Revista Medical Property Data Now Available for the Mid-Atlantic, Southeast and Midwest Regions 3Health News:Revista Medical Property Data Now Available for the Mid-Atlantic, Southeast and Midwest Regions 4Health News:Revista Medical Property Data Now Available for the Mid-Atlantic, Southeast and Midwest Regions 5Health News:Fewer U.S. Teens Using Sunscreen, Study Finds 2
... has found a strong relationship between negative mood and ... at London Health Sciences Centre , London, Canada, said ... the importance of couples emotional health during IVF treatment, ... ,A reduction in the incidence of multiple pregnancies ...
... be given some tips on how to raise their kids ... government is hoping that its 23million pounds scheme of using ... fathers, as it makes the use of male-friendly gadgets and ... ,Under the new initiative, "Parent Know-How", parents will ...
... Moss and superstar footballer David Beckham are among celebrities whose ... auction . ,Artist Rich Clarke, who created the ... 'Dexter' that follows a serial killer, working for the police ... specifically assigned the task of making these artworks by FX ...
... invasive method of treating cancer and they hope ... cancer soon . ,The development of ... result of the efforts of Virginia Techbiomedical engineer ... professor Boris Rubinsky. ,For decades, ...
... has brought some 700 players from 51 countries to Paris ... the growth of the "electronic sports" industry . ... pool of 180,000 dollars (132,000 euros) in prize money at ... the Games-Services company. It was taking place at a convention ...
... the main suspects in fatal neurodegenerative diseases such as ... -- remain mostly a mystery to scientists. Very few ... propagate is not fully understood. ,New insights ... Susan Liebman, distinguished university professor of biological sciences at ...
Cached Medicine News:Health News:Womens Mood Plays a Key Role in Infertility Treatment 2Health News:Scientists Destroy Cancer Cells Using Electric Pulses 2Health News:New Insights into Prion Propogation 2
(Date:8/21/2014)... , Aug. 21, 2014  Vermillion, Inc. (NASDAQ: ... on gynecologic cancers and women,s health, has appointed ... and Managed Markets. Ms. Bauzon has a ... expanding payer coverage for laboratory services companies. She has ... with PerkinElmer, Inc., where she held the position of ...
(Date:8/21/2014)... 21, 2014  Publicis Groupe customer engagement agency ... Partner and Healthcare Industry Group Leader, has been featured ... the most inspiring people in the life-sciences industry. Those ... and development, marketing, technology, creativity, strategy and medicine. ... a partner in its leading Rosetta Consulting practice. In ...
(Date:8/21/2014)... CHARLOTTE, N.C. , Aug. 21, 2014 /PRNewswire-iReach/ ... Home Medical Equipment, Inc. for the third straight ... annual Inc. 500|5000, an exclusive ranking of the ... most comprehensive look at the most important segment ... Yelp, Pandora, Timberland, Dell, Domino,s Pizza, LinkedIn, Zillow, ...
Breaking Medicine Technology:Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2Shannon Hartley Shines in PharmaVOICE 100 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 3
... Kendle (Nasdaq: KNDL ), a leading, global ... of a planned succession Senior Vice President and COO Stephen ... Chairman and CEO Candace Kendle, PharmD, will continue to serve ... COO from Dr. Cutler will be Jamie Macdonald, who brings ...
... 14, 2011 Zoledronic acid (sold by Novartis as ... Tumor Metastasis, and Paget,s Disease with sales of $2 ... such as post-dose syndrome and osteonecrosis of the jaw. ... the administration of Zoledronic acid in combination with another ...
Cached Medicine Technology:Kendle Announces CEO Succession Plan, Promotes Stephen Cutler, PhD, to President and CEO 2Kendle Announces CEO Succession Plan, Promotes Stephen Cutler, PhD, to President and CEO 3Kendle Announces CEO Succession Plan, Promotes Stephen Cutler, PhD, to President and CEO 4ICAP Ocean Tomo Announces Patents for a New and Safer Method of Treatment of Osteoporosis and Tumor Metastasis Using a Novel Zoledronic Acid Combination 2
... and available as a 4-up or ... the wings of the EnduriCuff Plus, ... This is recommended for uses that ... print a lot of wristbands on ...
... a label-based patient ID system which combines the ... and up to six alert or warning ID ... ID band worn by hospital patients. It integrates ... blood banks into a multipurpose ID band that ...
... facilitates bedside labeling of all laboratory ... and nursing personnel where the ID ... combination admitting ID band and designed ... identification system in facilities where alert ...
... The AeroScout Location Receiver is ... AeroScout Visibility System to outdoor and ... robust and sophisticated location measurement capabilities ... devices designed for harsh conditions. The ...
Medicine Products: