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Tymlos Approval History

  • FDA approved: Yes (First approved April 28th, 2017)
  • Brand name: Tymlos
  • Generic name: abaloparatide
  • Dosage form: Injection
  • Company: Radius Health, Inc.
  • Treatment for: Osteoporosis

Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis.

Development History and FDA Approval Process for Tymlos

DateArticle
Apr 28, 2017Approval FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Mar 10, 2017Radius Health Receives Notification of PDUFA Extension for Abaloparatide-SC
Sep 18, 2016Radius Announces Publication of Additional Positive Results from the Phase 3 ACTIVE Trial of Abaloparatide-SC in JBMR
May 31, 2016Radius Announces FDA Acceptance for Filing of NDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis
Mar 30, 2016Radius Health Submits NDA to the U.S. FDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis

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