Bonsity FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on Oct 8, 2019.
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
|Oct 7, 2019||FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis|
|Dec 10, 2018||Pfenex Submits New Drug Application to U.S. FDA Seeking Approval of PF708 for the Treatment of Osteoporosis|
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