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Bonsity 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 History and FDA Approval Process for Bonsity

DateArticle
Oct  7, 2019Approval FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis
Dec 10, 2018Pfenex Submits New Drug Application to U.S. FDA Seeking Approval of PF708 for the Treatment of Osteoporosis

Further information

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