U.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 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 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...
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 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 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 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 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 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 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 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...
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 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 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 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 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 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 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 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 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...
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