USV teriparatide
Teriparatide biosimilar developed by USV. Reference product Forsteo (Forteo in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: USV
FDAnot listed
EMAnot listed
CDSCOAug 2012permitted
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
USV Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2012
Application or permission
MF-179/2012; drug substance Bulk-255/2012 (September 2012)
Indications as licensed
Postmenopausal women with osteoporosis at high risk of fracture
Presentations
750 micrograms in 3 mL vial
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2012CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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