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020541_anastrozole_WR_BPCA.pdf

https://www.fda.gov/media/71590/download

… 020541_anastrozole_WR_BPCA.pdf …

022214s000_Anastrozole (Arimidex)_Clinpharm_BPCA

https://www.fda.gov/media/75522/download

… 022214s000_Anastrozole (Arimidex)_Clinpharm_BPCA …

022214s000_Anastrozole (Arimidex)_Clinical_BPCA

https://www.fda.gov/media/75520/download

… 022214s000_Anastrozole (Arimidex)_Clinical_BPCA …

022214s000_Anastrozole (Arimidex)_Statistical_BPCA

https://www.fda.gov/media/75525/download

… 022214s000_Anastrozole (Arimidex)_Statistical_BPCA …

2012 Notifications

https://www.fda.gov/drugs/resources-information-approved-drugs/2012-notifications

… exemestane, after failure of treatment with letrozole or anastrozole. More Information. 34 July 20, 2012 FDA granted …

FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-initial-therapy-hr-positive-her2-negative-metastatic-breast-cancer

… twice daily, plus physician’s choice of letrozole or anastrozole. The estimated median progression-free survival …

April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/april-june-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event

… need for regulatory action. Aromatase inhibitors Arimidex (anastrozole) Aromasin (exemestane) Femara (letrozole) Generic …

Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)

https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/accelerated-and-restricted-approvals-under-subpart-h-drugs-and-subpart-e-biologics

… (CML). Follow-up is limited. 20541 SE1 010 Arimidex anastrozole 5-Mar-02 5-Sep-02 6.0 S Provides for the use of ARIMIDEX (anastrozole) Tablets for adjuvant treatment of postmenopausal …

Use of Cyclin-Dependent Kinase 4/6 Inhibitor with Hormonal Therapy in Metastatic Breast Cancer—Efficacy in Patient Subgroups

https://www.fda.gov/drugs/science-and-research-drugs/use-cyclin-dependent-kinase-46-inhibitor-hormonal-therapy-metastatic-breast-cancer-efficacy-patient

… a hormonal agent (an aromatase inhibitor [letrozole or anastrozole] or fulvestrant) together with either a CDK 4/6 …

Verified Clinical Benefit | Cancer Accelerated Approvals

https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals

… chromosome positive CML 12/20/2002 5/27/2009 Arimidex (anastrozole) Adjuvant treatment of postmenopausal women with …

List of Determinations Including Written Request

https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request

… KB] Amendment 1 [PDF -168 KB] Amendment 2 [PDF -160 KB] Anastrozole AstraZeneca 11/14/2007 Written Request - …

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012

https://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-pediatric-assessments-conducted-under-prea-2007

… (PDF -67KB) Clinical pharmacology (PDF -264KB) None PREA Anastrozole - Arimidex AstraZeneca Medical (PDF -2MB) …

Drug-Induced Liver Injury Severity and Toxicity (DILIst) Dataset

https://www.fda.gov/science-research/liver-toxicity-knowledge-base-ltkb/drug-induced-liver-injury-severity-and-toxicity-dilist-dataset

… 150 primidone 0 Oral 151 vinorelbine 0 Intravenous 152 anastrozole 1 Oral 153 rabeprazole 1 Oral 154 azithromycin 1 …

Selected FDA Publications Related to the Application, Characterization, Effects, and Evaluation of Nanotechnology

https://www.fda.gov/science-research/nanotechnology-programs-fda/selected-fda-publications-related-application-characterization-effects-and-evaluation-nanotechnology

… Hussain, M. D.; Khan, M. A.; Habib, M. J. Formulation of anastrozole microparticles as biodegradable anticancer drug …

Table of Pharmacogenomic Biomarkers in Drug Labeling

https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling

… Populations, Clinical Pharmacology, Clinical Studies Anastrozole Oncology ESR, PGR (Hormone Receptor) Indications …

Drug Induced Liver Injury Rank (DILIrank) Dataset

https://www.fda.gov/science-research/liver-toxicity-knowledge-base-ltkb/drug-induced-liver-injury-rank-dilirank-dataset

… 5 Adverse reactions Less-DILI-Concern 1 LT00263 anastrozole 3 Adverse reactions Less-DILI-Concern 2 LT00277 …

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