U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticleFDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine)
DUBLIN, Ireland, March 8, 2017 /PRNewswire/ -- Allergan plc AGN, -1.14% a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing...
View ArticleFDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine)
DUBLIN, Ireland, March 8, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...
View ArticleNew Study Published in JAMA Psychiatry Found Three-Month Paliperidone...
TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticleFDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine)
DUBLIN, Ireland, March 8, 2017 /PRNewswire/ -- Allergan plc AGN, -1.14% a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing...
View ArticleModeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleAripiprazole once-monthly shows superior effectiveness to paliperidone...
(Source: H Lundbeck A/S) The head-to-head QUALIFY study compared the effectiveness of aripiprazole once-monthly to paliperidone palmitate once-monthly in adult patients with schizophrenia Patients...
View ArticleAlkermes to Present Data on Two-Month Dosing Option Of ARISTADA® at 16th...
Alkermes to Present Data on Two-Month Dosing Option Of ARISTADA ® at 16 th International Congress on Schizophrenia Research – Supplemental New Drug Application for ARISTADA Two-Month Dose Under Review...
View ArticleAlkermes to Present Data on Two-Month Dosing Option Of ARISTADA® at 16th...
Alkermes to Present Data on Two-Month Dosing Option Of ARISTADA® at 16th International Congress on Schizophrenia Research - Supplemental New Drug Application for ARISTADA Two-Month Dose Under Review by...
View ArticleFDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine)
DUBLIN, Ireland, March 8, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticlePre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole)...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of...
View ArticleVanda Announces Listing of a New Fanapt® Patent in the FDA Orange Book
WASHINGTON, Jan. 16, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a Fanapt® patent, number 8,586,610 ('610 patent), is now listed in the U.S. Food and...
View ArticleNew Study Published in JAMA Psychiatry Found Three-Month Paliperidone...
TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticleModeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleCariprazine Approved for Schizophrenia, Bipolar Disorder (ASHP - American...
(Source: ASHP - American Society of Health-System Pharmacists) BETHESDA, MD 18 Sep 2015- FDA and Actavis on September 17 announced the approval of cariprazine oral capsules for the treatment of...
View ArticleFDA Approves Carnexiv™ (carbamazepine) injection as Intravenous Short-Term...
FDA Approves Carnexiv™ (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types Carnexiv is the first FDA-approved intravenous carbamazepine option Healthcare...
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