Navigation Links
Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application

ROCKVILLE, Md., Nov. 27 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. Acceptance of the NDA confirms that the application is sufficiently complete for FDA review.

About Schizophrenia

Schizophrenia is a chronic, severe and disabling brain disorder that affects approximately one percent of Americans. Patients suffering from schizophrenia exhibit a range of symptoms, which include positive symptoms such as hallucinations, delusions, negative symptoms such as emotional withdrawal and cognitive symptoms associated with significant impairment in social and occupational functioning.

Unmet Needs in Schizophrenia

Although there are many drugs approved to treat schizophrenia, including the commonly prescribed "atypical antipsychotics," a high degree of dissatisfaction remains among physicians and patients. The recent CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, conducted by the National Institute of Mental Health (NIMH) and reported in The New England Journal of Medicine, evaluated several antipsychotic medications and revealed that 74% of patients taking antipsychotics discontinued treatment within 18 months, primarily because of insufficient efficacy and tolerability issues.

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. In addition to iloperidone, Vanda is developing VEC- 162, a compound for the treatment of sleep and mood disorders which is currently in Phase III development for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in Phase II development for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals Inc., please visit

Note Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda's plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vanda is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, a failure of Vanda's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, a lack of acceptance of Vanda's product candidates in the marketplace, a failure of the company to become or remain profitable, Vanda's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors that are described in the "Risk Factors" section (Part II, Item 1A) of Vanda's report on Form 10-Q for the quarter ended September 30, 2007 (File No. 000-51863). No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
2. Vanda Pharmaceuticals Reports Third Quarter 2007 Results
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
9. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
Post Your Comments:
(Date:11/24/2015)... -- The uptake of recently approved and pipeline premium products ... market growth to 2021, says GBI Research . ... for Type 1 Diabetes Mellitus (T1DM), will be a key driver of ... --> The uptake of recently approved and pipeline premium ... of market growth to 2021, says GBI Research ...
(Date:11/24/2015)... 24, 2015   Renowned ... deliver s advice and insights on ... More than 50% of Dubai ... according to the DHA   femMED launches comprehensive solutions for ... Dubai residents are not consuming enough to keep ...
(Date:11/24/2015)...  Freudenberg Medical has developed specialty tubing for an inexpensive, ... facilities. Africa and ... Nevertheless, prompt diagnosis is important to treat those affected and ... the help of a portable mini-lab or "lab on a ... affected areas and perform rapid testing for HIV. They do ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... ... their Black Friday sale a week early, offering 40% off select bras and ... intimate apparel industry through both mobile fit technology and the latest fashion, quickly ...
(Date:11/24/2015)... ... November 24, 2015 , ... DMG Productions announced that they will ... first quarter 2016 via Discovery Channel. Dates and show times TBA. , Aphria, Inc., ... in the business of producing and supplying medical marijuana pursuant to the Marijuana for ...
(Date:11/24/2015)... City, UT (PRWEB) , ... November 24, 2015 , ... ... Forbes Magazine. For a business, it is critical that the first impression be positive ... business, they are not likely to buy anything or want to return. They will ...
(Date:11/24/2015)... Richey, FL (PRWEB) , ... November 24, 2015 , ... ... deems a growing epidemic as deaths from prescription opioids in the United States grew ... and cocaine. In 2013 alone, opioids were involved in 37 percent of all fatal ...
(Date:11/24/2015)... ALEXANDRIA, VA (PRWEB) , ... November 24, 2015 ... ... encourages people across the United States to support their local poison centers through ... been designated as #GivingTuesday: calls it “a day that inspires people to ...
Breaking Medicine News(10 mins):