DRUG therapy for schizophreniaARIPIPRAZOLEBIOSENSORSDRUG approvalTHERAPEUTICSThe U.S. Food and Drug Administration last month approved the first drug in the United States with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the ...
FDA approves Abilify for adolescent patients with schizophrenia.The article reports on the decision of the U.S. Food and Drug Administration (FDA) to approve Abilify for the treatment of schizophrenia in adolescents ages 13-17 in the U.S. The approval is based on results of a study that ...
Lannett Company Inc. recently announced that its subsidiary, Silarx Pharmaceuticals Inc., received FDA approval for its abbreviated new drug application for aripiprazole oral solution. The aripiprazole oral solution 1 mg/mL is the generic version of Abilify (Otsuk...
5. https://www.lek.com/sites/default/files/insights/pdf-attachments/2014-FDA-approved-digital-pill-what-it-means-for-pharma.pdf 6.https://www.proteus.com/press-releases/otsuka-and-proteus-announce-the-first-us-fda-approval-of-a-digital-medicine-system-abilify-mycite/ 作者:韩东池 中山大学生物...
The FDA today approved generic versions of Abilify for treatment of schizophrenia and bipolar disorder.FDA approval for marketing multiple strengths and dosage forms of aripiprazole has been granted to Alembic Pharmaceuticals, Hetero Labs, Teva Pharmace...
FDA's approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.doi:http://formularyjournal.modernmedicine.com/node/405850T...
ABILIFYDISCMELT(aripiprazole)OrallyDisintegratingTablets ABILIFY®(aripiprazole)OralSolutionWARNINGSANDPRECAUTIONS ABILIFY®(aripiprazole)InjectionFORINTRAMUSCULARUSEONLY•CerebrovascularAdverseReactionsinElderlyPatientswith InitialU.S.Approval:2002Dementia-RelatedPsychosis:Increasedincidenceof cerebrovascularadversereactions(...
In an almost Kafkaesque twist and why Otsuka is upset, Abilify's patent protection is set to expire April 20, opening it to generic competition. The orphan drug approval for treating Tourette's was Otsuka's way of keeping Abilify on the market as well as its new indication for an additiona...
005ABILIFYARIPIPRAZOLETABLET, ORALLY DISINTEGRATING;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**YesNoNone2006/06/07Discontinued 批准日期,申请提交历史,通知信,药品说明书,审评文件等信息 ...
Despite the safety concerns, Laughren and other FDA officials acknowledged the need for additional drugs to treat schizophrenia and bipolar disorder in teenagers and older children. Currently only two drugs are cleared for those uses: Johnson & Johnson's Risperdal and Bristol-Myers Squibb's Abilify...