Ambio Announces US FDA Approval of a Generic Version of Forteo
WESTON, Fla., Nov. 21, 2023 /PRNewswire/ - Apotex Corp. announced today the launch of Teriparatide Injection, a single-patient-use pre-filled pen used for the treatment of osteoporosis in the United States.
Teva Announces Approval of a Generic Version of Forteo, in the U.S.
Apotex`s Generic Teriparatide Receives Approval in the U.S.
Strides Pharma`s Kauliv (teriparatide) Receives Approval in Europe
Strides Pharma`s Approved Kauliv ( Teriparatide) In Europe
JERUSALEM, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, announced today the successful conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (FDA) that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613 (oral hPTH (1-34), teriparatide tablets) under the 505(b)(2) regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients.
Rani Therapeutics Announces Positive Topline Results from Ph1 Study of RT-102
Accord Healthcare Sondelbay (teriparatide) Receives Approval in Europe