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Modeling 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...

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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...

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Pre-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...

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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...

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Cariprazine 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...

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Modeling 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 Article

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 Article

Pre-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 Article


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 Article


New 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...

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Modeling 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 Article

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 Article

Pre-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 Article


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 Article

Cariprazine 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 Article


Modeling 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 Article

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 Article


Pre-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 Article

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 Article

New 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 Article
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