Caspofungin Injection

… R = Resistant … Center for Drug Evaluation and Research … Caspofungin Injection … Drugs … Caspofungin Injection …

021227_Caspofungin_Statistical_BPCA.pdf

… CLINICAL STUDIES 21-227 SE5-021 Cancidas™ for injection (caspofungin acetate) Pediatric use from 3 months through 17 … studies provide evidence to support the use of caspofungin in children. The results of one study suggest that the use of caspofungin for the treatment of documented invasive …

021227_Caspofungin_Clinical_BPCA.pdf

… Review Completion Date July 10, 2008 Established Name Caspofungin acetate (Proposed) Trade Name Cancidas® … and Eileen Navarro, M.D. NDA 21-227, S-021 Cancidas® (caspofungin acetate) Table of Contents 1 RECOMMENDATIONS/RISK … and Eileen Navarro, M.D. NDA 21-227, S-021 Cancidas® (caspofungin acetate) 7 REVIEW OF SAFETY BY JULIE-ANN CREWALK, …

021227_Caspofungin_Clinpharm_BPCA.pdf

… CLINICAL PHARMACOLOGY REVIEW NDA 21-227 Drug Caspofungin Date of Submission 01/31/08 Trade Name Cancidas™ … Summary The applicant is seeking approval of Cancidas™ (caspofungin), an antifungal agent belonging to the … for duration of treatment based on the patients’ response. Caspofungin is a semisynthetic cyclic lipopeptide belonging …

021227_Caspofungin_WR_Amend_4.pdf

… 2001, Written Request for pediatric studies for Cancidas™ (caspofungin acetate), for Injection, 50 mg/vial and 70 … study examining the safety, tolerability, and efficacy of caspofungin acetate in pediatric patients with persistent … study examining the safety, tolerability and efficacy of caspofungin acetate in pediatric patients with documented …

Drug Trials Snapshots: REZZAYO

… were randomized in a 1:1 ratio to receive REZZAYO or caspofungin. Randomization was stratified based on diagnosis … weekly for a total of two to four doses. Patients in the caspofungin arm were to receive a single 70 mg IV loading dose followed by caspofungin 50 mg IV once daily treatment for a total of 2 to …

2017 First Generic Drug Approvals

… consistent with multiple sclerosis          57   207650 Caspofungin Acetate for Injection , 50 mg (base)/vial and 70 … Single Dose Vials Mylan Laboratories Limited Cancidas (Caspofungin Acetate) Injection , 50 mg (base)/vial and 70 mg … refractory to or intolerant of other therapies 56  207092  Caspofungin Acetate for Injection , 50 mg (base)/vial and 70 …

Antifungal Susceptibility Test Interpretive Criteria

… B* Injection No No Anidulafungin Injection Yes No Caspofungin Injection Yes No Fluconazole Injection, Oral Yes …

CDER Nitrosamine Impurity Acceptable Intake Limits

… N-nitroso-carvedilol Carvedilol 3 400 ng/day N-nitroso-caspofungin Caspofungin 4 1500 ng/day N-nitroso-desmethyl-chlophedianol …

Antimicrobial Resistance

… cleared the Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899), … to determine the minimum inhibitory concentration of Caspofungin, an antifungal agent with updated breakpoints for … July 12, 2022: The FDA cleared the VITEK 2 AST-Yeast Caspofungin (≤0.125 - ≥8 µg/mL) (K213899), a miniaturized, …

List of Determinations Including Written Request

… -96KB] Amendment 2 [PDF -136KB] Amendment 3 [PDF -156KB] Caspofungin Merck & Co., Inc. 4/15/2008 Written Request - …

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

… pharmacology (PDF -991KB) Statistical (PDF -435KB) BPCA Caspofungin acetate - Cancidas Merck Medical (PDF -3MB) …

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

… 493 cefditoren 0 Oral 494 zoledronate 1 Intravenous 495 caspofungin 0 Intravenous 496 atovaquone 0 Oral 497 …

Drug Induced Liver Injury Rank (DILIrank) Dataset

… Warnings and precautions Ambiguous DILI-concern 2 LT01089 caspofungin 7 Warnings and precautions Ambiguous DILI-concern …

January 24, 2023 Meeting of the Antimicrobial Drugs Advisory Committee- Cidara Presentations

… for Candidemia and Invasive Candidiasis1  Anidulafungin, caspofungin, and micafungin  Well-established efficacy and … Candida species (n) MIC90 (µg/mL) Rezafungin Anidulafungin Caspofungin Micafungin C. albicans (2,370) 0.06 0.06 0.03 … mg Weekly (N = 81) Rezafungin 400 / 200 mg Weekly (N = 57) Caspofungin 70 / 50 mg Daily (N = 36) Caspofungin 70 / 50 mg …

Kartsonis, Nicholas - Unredacted CV 2019.05.19

… NA, Komada Y. Safety, efficacy, and pharmacokinetics of caspofungin in Japanese pediatric patients with invasive … M, Bi S, Chow J, Ngai A, Winchell G, Kartsonis N, Stone J. Caspofungin exposure-response relationships in adult patients … Comparative Study of the Safety and Efficacy of Caspofungin vs. Micafungin in the Treatment of Candidiasis & …

January 24, 2023 Meeting of the Antimicrobial Drugs Advisory Committee- FDA Presentations

… to high-dose rezafungin, low-dose rezafungin, or caspofungin group (Part A). • High-dose rezafungin: 400 mg on … mg on Day 8; optional 200 mg dose on Day 15 and Day 22 • Caspofungin: 70 mg loading dose on Day 1 and then 50 mg/day … (high-dose, later changed to low-dose group) and caspofungin group. www.fda.gov 4 Phase 2 Trial: Interim …

Session 2 Berman

… pneumonitis) 7 ≥ 2.5 months to > 2 years (multiple azoles, caspofungin, neb amph B, terbinafine) Favorable response in 6 … syndrome) 1 1 month (IV isavuconazole, IV voriconazole, caspofungin, IV amph B, neb amph B) Favorable response (treated for 6 weeks) ABPA 1 > 12 years (azole, caspofungin, neb amph B, IV amph B) Favorable response …

January 24, 2023 Meeting of the Antimicrobial Drugs Advisory Committee- FDA Briefing Document

… 24 Table 15. In Vitro Activities (µg/mL) of Anidulafungin, Caspofungin, and Rezafungin Against Isolates of Candida spp. … 16. In Vitro Activities of Rezafungin, Anidulafungin, and Caspofungin Against Azole- Susceptible and -Nonsusceptible … Rezafungin Arm and a ≥2% Risk Difference Compared to the Caspofungin Arm, Safety Population, ISS …

Session-2-Peter-Pappas

… the candidemia mega-trials? Unlikely. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive … mITT Population Isavuconazole (n=199) Caspofungin (n=201) Adjusted Difference1 (95% CI) Response … pts, RCT, DB, dose ranging study comparing CD 101 to caspofungin followed by fluconazole. Focus on AF-resistant …

dictrank_dataset_508.xlsx

… LEVOLEUCOVORIN CALCIUM PENTAHYDRATE NA no no CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE Mixed ar less myocardial …

Mycamine label 4.2014

… in the Mycamine 100 mg/day, Mycamine 150 mg/day, and caspofungin (a 70 mg loading dose followed by a 50 mg/day … Term) Mycamine 100 mg n (%) Mycamine 150 mg n (%) Caspofungin n (%) Number of Patients 200 202 193 Gastrointes … mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin) In a second, supportive, randomized, …

Session-1-Thomas-Walsh

… DAmB LAmB ABLC Fluconazole Voriconazole Isavuconazole Caspofungin Micafungin Anidulafungin Hematogenous Candida … B lipid complex • amphotericin B colloidal dispersion • caspofungin • micafungin • anidulafungin • voriconazole • …

Additions/Deletions for Prescription and OTC Drug Product Lists May 2018

… A> @ 1GM/100ML (10MG/ML) A091478 001 Nov 23, 2011 May DISC CASPOFUNGIN ACETATE > A> POWDER;INTRAVENOUS > A> CANCIDAS > … A> AP +! 70MG/VIAL N021227 002 Jan 26, 2001 May CDFR > A> CASPOFUNGIN ACETATE > A> AP FRESENIUS KABI USA 50MG/VIAL … D> AP +! 70MG/VIAL N021227 002 Jan 26, 2001 May CDFR > D> CASPOFUNGIN ACETATE > D> AP FRESENIUS KABI USA 50MG/VIAL …

Orange Book Appendix A

… PHOSPHATE, CARVEDILOL PHOSPHATE CASODEX, BICALUTAMIDE CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE CASPORYN HC, HYDROCORTISONE CATAFLAM, …