Navigation Links
FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
Date:11/20/2008

ROCKVILLE, Md., Nov. 20 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA).

Vanda's resubmission was a Complete Response to the not approvable action letter that the company received on July 25, 2008. The FDA has indicated that it has accepted the Complete Response for review and has set a new target action date of May 6, 2009.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," and similar expressions or words, identify forward-looking statements. 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 the company's forward-looking statements include, among others: delays in the completion of Vanda's clinical trials; a failure of Vanda's product candidates to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements; a lack of acceptance of Vanda's product candidates in the marketplace, or a failure to become or remain profitable; Vanda's inability to obtain the capital necessary to fund its research and development activities; Vanda's failure to identify or obtain rights to new product candidates; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products under its license and sublicense agreements and other factors that are described in the "Risk Factors" section (Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the quarter ended September 30, 2008 (File No. 000-51863). In addition to the risks described above and in Part II, Item 1A of Vanda's quarterly report on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Vanda Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
2. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
3. American Stock Exchange Accepts Encisions Plan to Regain Compliance
4. Governor Rendell Accepts National Health Care Reform Pioneer Award
5. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
6. Lieutenant Governor Catherine Baker Knoll Accepts Women in Government Presidential Leadership Award
7. ev3 Inc. Accepts Resignation of Dr. John Simpson
8. Mike Huckabee Accepts Values Voter Presidential Debate
9. AMEX Accepts Lorus Plan to Meet AMEXs Continued Listing Standards
10. Partnering With MyPyramid: NUTRIKIDS Accepts the Challenge to Help Families Step Up to Healthier Living
11. FDA Accepts Gentas NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Grove Investment Group (TGIG), has initiated cultivation and processing operations at its production ... and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... 2016  Experian Health, the healthcare industry ... patient payment and care experience, today announced ... and services that will enhance the breadth ... These award-winning solutions will enable healthcare professionals ... in an ever-changing environment and redefine front-office ...
Breaking Medicine Technology: