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Tymlos FDA Approval History

FDA Approved: Yes (First approved April 28, 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 Timeline 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
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

Further information

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