Teriparatide Teva (teriparatide)

ANDA 208569

Teriparatide Teva (teriparatide)

ANDA 208569

U.S. License Holder:

Teva / Antares

Date of License:

November-16-2023

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications

TERIPARATIDE TEVA (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture;

Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture;

Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Teva-teriparatide (Teva) (June-2020)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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