Palopegteriparatide

FDA Drug Profile — Yorvipath

Drug Details

Generic Name
Palopegteriparatide
Brand Names
Yorvipath
Application Number
NDA216490
Sponsor
Ascendis Pharma, Endocrinology, Inc.
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION, POWDER
Routes
SUBCUTANEOUS
Active Ingredients
PALOPEGTERIPARATIDE

Indications and Usage

1 INDICATIONS AND USAGE YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use : Not studied for acute post-surgical hypoparathyroidism. ( 1 ) Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. ( 1 ) Limitations of Use YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH's titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment [see Dosage and Administration (2.3 , 2.4) and Clinical Studies (14) ] .