Teva Launches Generic Abilify® Tablets in the United States (Teva...
(Source: Teva Pharmaceutical Industries Ltd) Teva Launches Generic Abilify® Tablets in the United States JERUSALEM--(BUSINESS WIRE)--Apr. 28, 2015-- Teva Pharmaceutical Industries Ltd., (NYSE:TEVA)...
View ArticleTeva Launches Generic Abilify® Tablets in the United States
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced the launch of the generic equivalent to Abilify® (aripiprazole) Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, in the United...
View ArticleU.S. FDA APPROVES THE LABELING UPDATE OF ABILIFY MAINTENA® (ARIPIPRAZOLE) FOR...
(Source: Otsuka Holdings Co Ltd) For Immediate Release Company name Otsuka Holdings Co., Ltd. Representative Tatsuo Higuchi President and Representative Director, CEO Code number 4578 First Section ,...
View ArticleUS FDA approves the labeling update of Abilify Maintena (aripiprazole) for...
(Source: H Lundbeck A/S) Valby, Denmark, and Tokyo, Japan, 7 December 2014, 2014-12-07 03:39 CET (GLOBE NEWSWIRE) -- Labeling update provides description of controlled clinical study of Abilify...
View ArticleU.S. FDA Approves The Labeling Update Of Abilify Maintena® (Aripiprazole) For...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals U.S. FDA Approves The Labeling Update Of Abilify Maintena ® (Aripiprazole) For Extended-Release Injectable Suspension To Describe New Clinical...
View ArticleNew Study Published in JAMA Psychiatry Found Three-Month Paliperidone...
(Source: Johnson & Johnson) Results served as basis for regulatory filing with U.S. Food and Drug Administration and designation as Priority Review TITUSVILLE, NJ, March 29, 2015 - Three-month...
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 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 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 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 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 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...
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 ArticleU.S. FDA Approves Dual-Chamber Syringe for Abilify Maintena® (aripiprazole)...
PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. Food and Drug Administration...
View ArticleFDA approves Rexulti (brexpiprazole) as adjunctive treatment for adults with...
(Source: H Lundbeck A/S) There are approximately 15 million adults in the US with major depressive disorder (MDD), and many of them have an inadequate response to monotherapy with antidepressants ....
View ArticleU.S. FDA APPROVES OTSUKA AND LUNDBECK’S REXULTI® (BREXPIPRAZOLE) AS...
(Source: Otsuka Holdings Co Ltd) For Immediate Release Company name Otsuka Holdings Co., Ltd. Representative Tatsuo Higuchi President and Representative Director, CEO Code number 4578 First Section ,...
View ArticleAllergan and Gedeon Richter Plc. Receive FDA Approval of VRAYLAR™...
DUBLIN and BUDAPEST, Hungary, Sept. 17, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. announced today that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR™...
View ArticleAllergan and Gedeon Richter Plc. Receive FDA Approval of VRAYLAR™...
(Source: Allergan plc) DUBLIN and BUDAPEST, Hungary, Sept. 17, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. announced today that the U.S. Food and Drug Administration (FDA) has...
View ArticleU.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and...
(Source: Otsuka America Pharmaceutical Inc) U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health The first Digital Medicine, a drug/device product,...
View ArticleAllergan and Gedeon Richter Plc. to Present Data on VRAYLAR (cariprazine) at...
DUBLIN and BUDAPEST, Hungary, Dec. 4, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced they will present data on VRAYLAR (cariprazine) in patients with...
View ArticleAlkermes Announces Achievement of Milestones for CNS Medicines in Proprietary...
(Source: Alkermes plc) Alkermes Announces Achievement of Milestones for CNS Medicines in Proprietary Product and Pipeline Portfolio -- Pivotal Programs Initiated for ALKS 3831 for Schizophrenia and...
View ArticleEuropean CHMP issues a positive opinion for a label update of Abilify...
(Source: H Lundbeck A/S) Labeling update (sections 5.1 and 4.4) provides description of controlled clinical study of Abilify Maintena for treating adult patients experiencing acute relapses of...
View ArticleAllergan Announces U.S. Availability of VRAYLAR™ (cariprazine) for Treatment...
(Source: Allergan plc) DUBLIN, March 16, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that VRAYLAR (cariprazine), a once-daily oral atypical...
View ArticleAllergan Announces U.S. Availability of VRAYLAR™ (cariprazine) for Treatment...
DUBLIN, March 16, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that VRAYLAR™ (cariprazine), a once-daily oral atypical antipsychotic, is now...
View ArticleU.S. FDA Accepts For Review Otsuka and Lundbeck’s sNDA Filing for Labeling...
(Source: Otsuka America Pharmaceutical Inc) U.S. FDA Accepts For Review Otsuka and Lundbeck's sNDA Filing for Labeling Update of REXULTI (brexpiprazole) for Maintenance Treatment of Schizophrenia The...
View ArticleAllergan and Richter Provide Update on Cariprazine Program (Allergan plc)
(Source: Allergan plc) DUBLIN, Ireland and BUDAPEST, Hungary, Aug. 5, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Gedeon Richter Plc., today provided a...
View ArticleAlkermes Submits Supplemental New Drug Application to FDA for Two-Month...
(Source: Alkermes plc) Alkermes Submits Supplemental New Drug Application to FDA for Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia -- Potential New Offering Would Expand Range of...
View ArticleAlkermes Submits Supplemental New Drug Application to FDA for Two-Month...
Alkermes Submits Supplemental New Drug Application to FDA for Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia –– Potential New Offering Would Expand Range of ARISTADA Doses to Three...
View ArticleUS FDA approves labeling update of Rexulti® (brexpiprazole) for maintenance...
(Source: H Lundbeck A/S) Valby, Denmark, 2016-09-24 00:30 CEST (GLOBE NEWSWIRE) -- Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance phase...
View ArticleUS FDA approves labeling update of Rexulti® (brexpiprazole) for maintenance...
Valby, Denmark, 2016-09-24 00:30 CEST (GLOBE NEWSWIRE) -- Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance phase of treatment Approval...
View ArticleAllergan and Gedeon Richter Plc. to Present Data on Cariprazine at the...
(Source: Allergan plc) DUBLIN and BUDAPEST, Hungary, May 12, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced that nine posters highlighting additional scientific...
View ArticleAlkermes to Present Data on Schizophrenia Portfolio at Upcoming Schizophrenia...
(Source: Alkermes plc) Alkermes to Present Data on Schizophrenia Portfolio at Upcoming Schizophrenia International Research Society Conference - Results From Positive Phase 2 Study of ALKS 3831 for the...
View ArticleAlkermes to Present Data on ALKS 5461 at Upcoming American Society of...
(Source: Alkermes plc) Alkermes to Present Data on ALKS 5461 at Upcoming American Society of Clinical Psychopharmacology Annual Meeting - Company to Host Webcast Presentation and Conference Call on...
View ArticleAlkermes to Present Data on ALKS 5461 at Upcoming American Society of...
Alkermes to Present Data on ALKS 5461 at Upcoming American Society of Clinical Psychopharmacology Annual Meeting — Company to Host Webcast Presentation and Conference Call on Wednesday, June 1 — —...
View ArticleFDA Issues Complete Response Letter for Digital Medicine New Drug Application...
(Source: Otsuka America Pharmaceutical Inc) Tokyo, Japan, and Redwood City, Calif. - April 26, 2016 -Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that...
View ArticleYoung adult patients* with schizophrenia show improved functioning and...
(Source: H Lundbeck A/S) Valby, 2015-06-23 17:47 CEST (GLOBE NEWSWIRE) -- For non-US media only • A newly released pre-specified subgroup analysis from the QUALIFY** study shows that younger adult...
View ArticleTeva Launches Generic Abilify® Tablets in the United States (Teva...
(Source: Teva Pharmaceuticals USA Inc) Teva Launches Generic Abilify® Tablets in the United States JERUSALEM--(BUSINESS WIRE)--Apr. 28, 2015-- Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today...
View ArticleU.S. FDA accepts for review a supplemental New Drug Application to expand...
Valby, Denmark, 2016-11-30 15:02 CET (GLOBE NEWSWIRE) -- Application seeks to expand Abilify Maintena label to include maintenance treatment for Bipolar I disorder If the label expansion is approved,...
View ArticleU.S. FDA accepts for review a supplemental New Drug Application to expand...
(Source: H Lundbeck A/S) Valby, Denmark, 2016-11-30 15:02 CET (GLOBE NEWSWIRE) -- Application seeks to expand Abilify Maintena label to include maintenance treatment for Bipolar I disorder If the label...
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 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 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 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 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 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...
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