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Daptomycin

Generic Name
Daptomycin
Brand Names
Cubicin, Dapzura, Daptomycin Hospira
Drug Type
Small Molecule
Chemical Formula
C72H101N17O26
CAS Number
103060-53-3
Unique Ingredient Identifier
NWQ5N31VKK

Overview

Daptomycin is a cyclic lipopeptide antibacterial agent with a broad spectrum of activity against Gram-positive bacteria, including methicillin-susceptible and -resistant Staphylococcus aureus (MSSA/MRSA) and vancomycin-resistant Enterococci (VRE). Chemically, daptomycin comprises 13 amino acids, including several non-standard and D-amino acids, with the C-terminal 10 amino acids forming an ester-linked ring and the N-terminal tryptophan covalently bonded to decanoic acid. Daptomycin was first discovered in the early 1980s by researchers at Eli Lilly in soil samples from Mount Ararat in Turkey. Early work on developing daptomycin was abandoned due to observed myopathy but was resumed in 1997 when Cubist Pharmaceuticals Inc. licensed daptomycin; it was found that a once-daily dosing scheme reduced side effects while retaining efficacy. Daptomycin was approved by the FDA on September 12, 2003, and is marketed under the name CUBICIN® by Cubist Pharmaceuticals LLC (Merck & Co.).

Background

Daptomycin is a cyclic lipopeptide antibacterial agent with a broad spectrum of activity against Gram-positive bacteria, including methicillin-susceptible and -resistant Staphylococcus aureus (MSSA/MRSA) and vancomycin-resistant Enterococci (VRE). Chemically, daptomycin comprises 13 amino acids, including several non-standard and D-amino acids, with the C-terminal 10 amino acids forming an ester-linked ring and the N-terminal tryptophan covalently bonded to decanoic acid. Daptomycin was first discovered in the early 1980s by researchers at Eli Lilly in soil samples from Mount Ararat in Turkey. Early work on developing daptomycin was abandoned due to observed myopathy but was resumed in 1997 when Cubist Pharmaceuticals Inc. licensed daptomycin; it was found that a once-daily dosing scheme reduced side effects while retaining efficacy. Daptomycin was approved by the FDA on September 12, 2003, and is marketed under the name CUBICIN® by Cubist Pharmaceuticals LLC (Merck & Co.).

Indication

Daptomycin is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in patients one year of age and older. It is also indicated for the treatment of Staphylococcus aureus bloodstream infections (bacteremia) in patients one year of age and older, including in adult patients with right-sided infective endocarditis. Daptomycin is not indicated for the treatment of pneumonia or left-sided infective endocarditis due to S. aureus. Use is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central). As with all antibacterial drugs, it is strongly suggested to perform sufficient testing before treatment initiation in order to confirm an infection caused by susceptible bacteria. Failure to do so may result in suboptimal treatment, treatment failure, and the development of drug-resistant bacteria.

Associated Conditions

  • Complicated Skin and Skin Structure Infection
  • Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)

FDA Approved Products

Daptomycin
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:500 mg in 10 mL
Approved: 2022/03/08
NDC:63323-371
DAPTOMYCIN
Manufacturer:Meitheal Pharmaceuticals Inc.
Route:INTRAVENOUS
Strength:350 mg in 7 mL
Approved: 2021/06/29
NDC:71288-017
Daptomycin
Manufacturer:Hospira, Inc.
Route:INTRAVENOUS
Strength:350 mg in 7 mL
Approved: 2022/08/18
NDC:0409-0120
Daptomycin
Manufacturer:Camber Pharmaceuticals, Inc.
Route:INTRAVENOUS
Strength:350 mg in 7 mL
Approved: 2023/01/04
NDC:31722-215
Daptomycin
Manufacturer:Xellia Pharmaceuticals USA, LLC
Route:INTRAVENOUS
Strength:350 mg in 7 mL
Approved: 2018/07/19
NDC:45932-0039

Singapore Approved Products

DAPTOMYCIN-AFT POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL
Manufacturer:QILU PHARMACEUTICAL (HAINAN) CO., LTD.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:500MG/VIAL
Online:Yes
Approved: 2023/11/28
Approval:SIN16900P
DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL
Manufacturer:Intas Pharmaceuticals Limited, INTAS PHARMACEUTICALS LIMITED
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:500mg/vial
Online:Yes
Approved: 2020/12/29
Approval:SIN16071P
PENMIX DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL
Manufacturer:Penmix Ltd
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:500 mg/vial
Online:Yes
Approved: 2023/06/27
Approval:SIN16813P
PFIZER DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL
Manufacturer:Hospira Australia Pty. Ltd.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:500mg/vial
Online:Yes
Approved: 2022/03/10
Approval:SIN16443P
BEDAPT DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL
Manufacturer:Biological E. Limited
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500MG/VIAL
Online:Yes
Approved: 2023/07/31
Approval:SIN16828P

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