Dalbavancin

Abstract

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The October 2014 monograph topics are ortitavancin diphosphate, insulin human inhalation powder, empaglifozin, efinaconazole topical solution, 10%, and tavaborole topical solution, 5%. The DUE/MUE is on oritavancin diphosphate.

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References

Dalvance (dalbavancin) [prescribing information]. Chicago, IL: Durata Therapeutics; May 2014.

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Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2005; 41(10): 1407–1415.

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Discover 1: A randomized, double-blind study of dalbavancin (DAL) compared to vancomycin (V) (with an option to switch to linezolid (L)) in treatment of acute bacterial skin and skin structure infections (abSSSI) [abstract]. Presented at: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 10–13, 2013; Denver, CO. Abstract L-201.

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Guidance for industry: Acute bacterial skin and skin structure infections: Developing drugs for treatment. US Food and Drug Administration Web site. October 2013. http://www.fda.gov/downloads/Drugs/…/Guidances/ucm071185.pdf. Accessed June 9, 2014.

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Geographic differences in the presentation and outcomes of acute bacterial skin and skin structure infections (ABSSSI) in the DISCOVER program [abstract]. Presented at: European Society of Clinical Microbiology and Infectious Diseases; May 10–13, 2014; Barcelona, Spain. Abstract P1818.

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Discover 2: A randomized, double-blind study of dalbavancin (DAL) compared to vancomycin (V) (with an option to switch to linezolid (L)) in treatment of acute bacterial skin and skin structure infections (ABSSSI) [abstract]. Presented at: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 10–13, 2013; Denver, CO. Abstract L-202.

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NDA approval letter: DALVANCE (dalbavancin; NDA 21-883). US Food and Drug Administration Web site. Published May 23, 2014. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021883Orig1s000ltr.pd. Accessed May 27, 2014.