FDA Approves Once-Monthly ABILIFY MAINTENA™ (Aripiprazole) For...
(Source: Otsuka Pharmaceutical Co Ltd) Otsuka Pharmaceutical Co., Ltd. March 1, 2013 FDA Approves Once-Monthly ABILIFY MAINTENA™ (Aripiprazole) For Extended-Release Injectable Suspension for the...
View ArticleU.S. FDA Approves Supplemental New Drug Applications for Once-Monthly...
TITUSVILLE, N.J., Nov. 13, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs)...
View ArticleStudy Observed Association between JANSSEN® CONNECT® Injection Centers and...
TITUSVILLE, N.J., Sept. 24, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced the results of a first-of-its-kind study, The Impact of JANSSEN® CONNECT® Injection Centers on Adherence to an...
View ArticleJanssen Submits New Drug Application to U.S. FDA for Three-Month Paliperidone...
TITUSVILLE, N.J., Nov. 19, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic...
View ArticleU.S. FDA Approves Supplemental New Drug Applications for Once-Monthly...
(Source: Johnson & Johnson) Approval via priority review based on positive data from long-term schizoaffective study measuring ability to delay relapse Titusville, NJ, November 13, 2014 - Janssen...
View ArticleSunovion Pharmaceuticals Inc. Announces Data Showing Latuda® (lurasidone HCl)...
A Similar Pattern of Metabolic Changes was Observed in Patients Who Received LATUDA as Monotherapy or as Adjunctive Therapy to Mood Stabilizers MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion...
View ArticleStudy Published in The Journal of Clinical Psychiatry Shows INVEGA SUSTENNA®...
TITUSVILLE, N.J., April 15, 2015 /PRNewswire/ -- A study published in The Journal of Clinical Psychiatry yesterday shows that long-acting INVEGA SUSTENNA® (paliperidone palmitate) was effective six...
View ArticleStudy Observed Association between JANSSEN® CONNECT® Injection Centers and...
(Source: Johnson & Johnson) JANSSEN® CONNECT® program seeks to provide people living with schizophrenia information and assistance to support healthcare provider-ordered long-acting antipsychotic...
View ArticleJanssen Submits New Drug Application to U.S. FDA for Three-Month Paliperidone...
(Source: Johnson & Johnson) First Long-Acting Treatment to be Used Four Times a Year for Schizophrenia in Adults TITUSVILLE, NJ, November 19, 2014 - Janssen Research & Development, LLC...
View ArticleJanssen Pharmaceuticals Seeks Expanded Label for Once-Monthly INVEGA®...
TITUSVILLE, N.J., July 14, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA)...
View ArticleStudy Published in The Journal of Clinical Psychiatry Shows INVEGA SUSTENNA®...
(Source: Johnson & Johnson) TITUSVILLE, N.J. , April 15, 2015 /PRNewswire/ -- A study published in TheJournal of Clinical Psychiatry yesterday shows that long-acting INVEGA SUSTENNA® (paliperidone...
View ArticleLandmark Study Shows Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA®...
First prospective, randomized clinical trial to reflect context of "real world" issues in treating schizophrenia, including recent incarceration and substance abuse TITUSVILLE, N.J., May 5, 2014...
View ArticleJanssen Investigational Treatment for Schizophrenia Shows Positive Efficacy,...
Independent Data Monitoring Committee Recommends Halting Trial and Unblinding Data Based on Treatment Efficacy TITUSVILLE, N.J., March 20, 2014 /PRNewswire/ -- Janssen Research & Development, LLC...
View ArticleSunovion Pharmaceuticals Inc. Presents Data Showing 12 Months of Latuda®...
Tweet Send to a Friend Presented at the 166th American Psychiatric Association Annual Meeting in San Francisco MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. today announced...
View ArticleFDA Grants Priority Review for Three-Month Paliperidone Palmitate for the...
TITUSVILLE, N.J., Jan. 19, 2015 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the...
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 ArticleForest to Acquire U.S. Marketing Rights to Saphris® (asenapine) from Merck...
(Source: Forest Laboratories Inc) Forest acquires exclusive rights to Saphris® in the United States for the treatment of schizophrenia and acute bipolar mania in adults for $240 million plus...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding the...
View ArticleActavis Announces FDA Acceptance of sNDA for SAPHRIS® (asenapine) for the...
Facebook Twitter Pinterest × DUBLIN, Nov. 13, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' Supplemental...
View ArticleStudy Found INVEGA® SUSTENNA® (paliperidone palmitate) Once-Monthly...
Demonstrated significant efficacy in manic and depressive mood symptoms and psychosis, and improved patient functioning TITUSVILLE, N.J., May 6, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc.,...
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