LG Life Sciences insulin glargine
Insulin glargine biosimilar developed by LG Life Sciences. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: LG Life Sciences (import)
FDAnot listed
EMAnot listed
CDSCODec 2011permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
LG Life Sciences
Pathway
Import and marketing permission
Approved
Dec 2011
Application or permission
Import permission
Indications as licensed
Type 1 and type 2 diabetes (adults)
Presentations
100 IU/mL vial and cartridge
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCODec 2011CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
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