FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date

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 r...

Vanda Pharmaceuticals to Present New Data on Iloperidone at the 2007 American Society of Human Genetics Annual Meeting

ROCKVILLE, Md., Oct. 22 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA ) announced today that it will present five posters on the pharmacogenetics of iloperidone at the 57th American Society of Human Genetics (ASHG) annual meeting to be held in San Diego, CA, from October ...

Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone

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 antipsychot...

Vanda Pharmaceuticals Responds to Announcement and Filing by a Group Led by Tang Capital Partners, LP

...ly over the past several months with the Food & Drug Administration ("FDA") to reevaluate its response to Vanda's New Drug Application ("NDA") for iloperidone for the treatment of schizophrenia. In September of 2008, management met with the FDA to discuss the FDA's not-approvable letter relating to the NDA ...

Iloperidone in Medical Technology

Vanda Presents Phase III Iloperidone Efficacy Data

Findings also demonstrate favorable safety and tolerability profile ROCKVILLE, Md., Dec. 12 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA ) announced today that data from four Phase III efficacy and safety trials demonstrate that iloperidone, an investigational atypical...

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 ...

Vanda Pharmaceuticals Submits Iloperidone New Drug Application

ROCKVILLE, Md., Sept. 27 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA ) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schiz...

Vanda Pharmaceuticals Provides Update on Iloperidone

ROCKVILLE, Md., Sept. 11 /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 it met with the FDA on Sep...

Vanda Pharmaceuticals to Present Data on Iloperidone at the 2007 American Psychiatric Association Annual Meeting

ROCKVILLE, Md., May 18, 2007 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. announced today that it will present four posters on iloperidone at the 160th American Psychiatric Association (APA) annual meeting which will be held at the San Diego Convention Center in San Diego, CA, from May 19 ...

Antipsychotic Iloperidone Results Show Favorable Akathisia Profile

SAN DIEGO, May 22, 2007 /PRNewswire-FirstCall/ -- According to study results presented today at the 2007 American Psychiatric Association annual meeting, iloperidone, an investigational atypical antipsychotic, was shown to have a favorable akathisia profile. Akathisia -- a debilitating sensation o...

Phase III Data Show Vanda Pharmaceuticals' Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

...enia for which Vanda submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in September 2007. The FDA accepted Vanda's iloperidone NDA for filing in November 2007 and Vanda expects a decision from the FDA on or about July 27, 2008. Vanda's second product candidate, tasimelteon (VE...

Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events

..., studying the efficacy and safety of iloperidone. iloperidone is a 5HT2/D2 antagonist ("atypical") antipsychotic...he efficacy and safety of iloperidone suggest that iloperidone could be a useful long-term treatment option for p...ently under review by the FDA and demonstrate that iloperidone is effective in the short-term treatment of schizo...

Vanda Pharmaceuticals Reports Third Quarter 2007 Results

... Submits iloperidone New Drug Application (NDA); Begins Phase III Chron...estone charge resulting from the submission of the iloperidone NDA, which was partially offset by lower clinical ...by lower clinical trial expenses for the company's iloperidone and VEC-162 Phase III trials that were primarily c...

Data Presented at SLEEP 2007 Shows VEC-162 Improves Sleep Onset and Maintenance vs. Placebo

...ing statements include, among others, a failure of iloperidone or Vanda's other product candidates to be demonstr...ctive, a failure to obtain regulatory approval for iloperidone or the company's other product candidates, a lack of acceptance of iloperidone or Vanda's other product candidates in the marketp...

Iloperidone in Biological Technology

Vanda Pharmaceuticals to Present Data on Fanapt(TM) and Tasimelteon at the 162nd American Psychiatric Association Annual Meeting

... to 10:30 am. NR1-033 Efficacy of iloperidone is Comparable to Risperidone in Analyses of a ...ia. NR1-026 The Comparative Efficacy of iloperidone and Haloperidol Across Four Short-Term Control...lymorphisms in the dopamine receptor 2 gene on iloperidone efficacy for the treatment of patients with schizo...

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Results

...ter of 2008 relative to the third quarter of 2008 is primarily due to lower iloperidone pre-commercial launch expenses and the decrease in stock-based compensation... primarily due to lower employee stock-based compensation expense and lower iloperidone pre-commercial launch expenses. For the full year of 2008, total G&A e...

Vanda Pharmaceuticals Reports Third Quarter 2008 Results

...er of 2008 relative to the second quarter of 2008 is primarily due to lower iloperidone pre-commercial launch expenses. The decrease in G&A expenses in the third q... primarily due to lower employee stock-based compensation expense and lower iloperidone pre-commercial launch expenses. -- Employee stock-based compensation expe...