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Bipolar Disorder News (Page 2)
Related terms: Bipolar Affective Disorder, Bipolar Affective Mood Disorder, Bipolar I Disorder, Manic Depression, Manic Depressive Disorder, Manic Depressive Illness, Mood Disorder, Bipolar, Bipolar Depression, Ultra Rapid Cycling, Bipolar II Disorder
Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for Caplyta (lumateperone) for Specific Patient Populations
Caplyta label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic impairment and patients who are concomitantly taking moderate or strong...
FDA Approves Igalmi (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) – BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop...
Intra-Cellular Therapies Announces U.S. FDA Approval of Caplyta (lumateperone) for the Treatment of Bipolar Depression in Adults
Caplyta is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or...
FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, June 1, 2021 /PRNewswire/ – Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment...
FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression
DUBLIN and BUDAPEST, Hungary, May 28, 2019 /PRNewswire/ – Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has approved a...
FDA Medwatch Alert: Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s i...
FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- March 6, 2018 – Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug...
FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication
November 13, 2017 – The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an...
Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
Valby, Denmark and Tokyo, Japan, 28 July 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced Abilify Maintena® (aripiprazole) for extended-release ...
FDA Medwatch Alert: Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions
ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the...
FDA Approves Vraylar (cariprazine) for Schizophrenia and Bipolar Disorder
September 17, 2015 – The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults. “Schizophrenia and bipolar disorder c...
Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder
DUBLIN, March 13, 2015 /PRNewswire/ – Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Saphris...
FDA Medwatch Alert: Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions
ISSUE: FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to ...
Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
Marlborough, Mass., June 28, 2013 – Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for the use of Latuda (lurasidone HCl) a...
FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
MOUNTAIN VIEW, Calif., Dec. 21, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Adasuve (loxapine) Inhalation Powder 10 mg ...
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