Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-02-05FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for TYMLOS (abaloparatide) from Radius Health, Inc., resulting in labeling updates via a supplem…
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FDA approval · 2018-01-24FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for Prolia (denosumab) from Amgen.
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FDA approval · 2017-11-07FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Conjugated Estrogens (Estrogens, Conjugated) submitted by Prasco Laboratories.
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FDA approval · 2017-11-01FDA Approved: MENOSTAR — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for MENOSTAR (estradiol) submitted by Bayer HealthCare Pharmaceuticals Inc. to update the produc…
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FDA approval · 2017-11-01FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Vivelle-Dot (estradiol) submitted by Sandoz Inc, updating the product’s labeling via a supplemen…
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FDA approval · 2017-11-01FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) from Wyeth/Pfizer to update the product labeling …
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FDA approval · 2017-10-31FDA Approved: IBANDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
The FDA approved Macleods Pharmaceuticals Limited's original ANDA for ibandronate sodium, a bisphosphonate, for the treatment and prevention…
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FDA approval · 2017-04-28FDA Approved: TYMLOS — Original Application (Radius Health, Inc.)
The FDA approved TYMLOS (abaloparatide) from Radius Health as the original NDA for the treatment of postmenopausal osteoporosis in women at …
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FDA approval · 2017-04-28FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories. This action pertains to a supplemental approv…
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FDA approval · 2017-02-10FDA Approved: ABIGALE LO — Original Application (Xiromed LLC)
FDA approved ABIGALE LO, a generic combination of estradiol and norethindrone acetate, under an Original Application by Xiromed LLC. It is a…
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FDA approval · 2016-10-12FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals Inc)
FDA approves the original application for raloxifene hydrochloride from ScieGen Pharmaceuticals Inc, providing a generic option for postmeno…
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FDA approval · 2016-08-18FDA Approved: ZOLEDRONIC ACID — Original Application (Fresenius Kabi USA, LLC)
FDA approved an Original Application for Zoledronic acid as a generic injectable product from Fresenius Kabi USA, LLC. The approval covers i…
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FDA approval · 2016-05-24FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc. The approval updates the product's labeli…
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FDA approval · 2016-05-04FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for PREMPRO, a combination of conjugated estrogens and medroxyprogesterone acetate, from Wyeth P…
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FDA approval · 2016-03-29FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC. This action indicates regula…
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FDA approval · 2016-03-22FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for Binosto (alendronate sodium) from Radius Health, Inc., updating the product labeling as part…
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FDA approval · 2016-03-22FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's original application for raloxifene hydrochloride (generic) for postmenopausal osteoporosis and for reducing the ris…
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FDA approval · 2016-03-11FDA Approved: IBANDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approves an Original Application for ibandronate sodium as a generic product (Aurobindo Pharma Limited), enabling its use for osteoporos…
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FDA approval · 2016-02-25FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PREMPRO (conjugated estrogens and medroxyprogesterone acetate) from Wyeth Pharmaceuticals (Pfize…
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FDA approval · 2015-12-09FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for risendronate sodium (generic risendronate) from Macleods Pharmaceuticals Limited.
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FDA approval · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for generic risedronate sodium (RISEDRONATE SODIUM), authorizing its marketing in the United State…
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FDA approval · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' risendronate sodium generic product under an Original Application (ANDA). Risendronate sodiu…
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FDA approval · 2015-11-23FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories.
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FDA approval · 2015-10-31FDA Approved: CALCITONIN SALMON — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application from Apotex Corp. for calcitonin salmon (generic), resulting in an updated approval under the ANDA p…
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FDA approval · 2015-10-31FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Calcitonin Salmon submitted by Endo USA, Inc.