Bonsity FDA Approval History
Last updated by Judith Stewart, BPharm on July 6, 2021.
FDA Approved: Yes (First approved October 4, 2019)
Brand name: Bonsity
Generic name: teriparatide
Dosage form: Injection
Previous Name: PF708
Company: Pfenex Inc.
Treatment for: Osteoporosis
Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
Bonsity is approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug.
Bonsity is 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.
Development timeline for Bonsity
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