for subcutaneous use Initial U.S. Approval: 2017
As specified in the prescribing information, abaloparatide injection is indicated for the treatment of osteoporosis. TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Facts about abaloparatide injection
Approval Date: 2017
Proprietary Name: TYMLOS (abaloparatide) injection
Active Ingredient(s): abaloparatide
FDA-approved use: osteoporosis
Dosage Form: Injection: 3120 mcg/1.56 mL (2000 mcg/mL) in a single-patient-use prefilled pen. The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcL of sterile, clear, colorless solution
Medicine Approved By: US FDA
Manufacturer: Radius Health, Inc.
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For abaloparatide injection
Approved accessible "abaloparatide injection"
Tymlos (abaloparatide) injection was first approved in 2017 to treat postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. In 2022, it was approved to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
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TYMLOS (abaloparatide) injection, for subcutaneous use Initial U.S. Approval: 2017
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