Postmenopausal Osteoporosis

• FDA approval · 2024-07-11
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for ibandronate sodium from Apotex Corp. under ANDA204222. This represents an update to the prev…

• FDA approval · 2024-06-13
  FDA Approved: ESTRADIOL — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Estradiol (ESTRADIOL) from NorthStar Rx LLC under the ANDA program.

• FDA approval · 2024-04-22
  FDA Approved: ESTRADIOL — Original Application (Solaris Pharma Corporation)

  FDA approves Solaris Pharma Corporation's Estradiol as an original application (generic) product for estrogen replacement therapy.

• EMA approval · 2024-04-12
  EMA Authorised: Eladynos (abaloparatide) — Theramex Ireland Limited

  EMA has authorised Eladynos (abaloparatide) for osteoporosis, including postmenopausal osteoporosis, with Theramex Ireland Limited as the MA…

• FDA approval · 2024-04-11
  FDA Approved: CALCITONIN SALMON — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved the original application for Calcitonin Salmon from Dr. Reddy's Laboratories, Inc., enabling the generic to enter the market.

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• FDA approval · 2024-04-09
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for Prolia (denosumab). This action likely updates the drug's labeling.

• FDA approval · 2024-03-05
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen. The action indicates an expanded or updated indication fo…

• FDA approval · 2024-03-04
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) submitted by Wyeth Pharmaceuticals LLC (a subsidiary …

• FDA approval · 2024-02-15
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…

• FDA approval · 2023-12-21
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  FDA approved a supplemental application for TYMLOS (abaloparatide) submitted by Radius Health, Inc., updating the labeling for osteoporosis …

• FDA approval · 2023-12-18
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industires Inc.)

  The FDA approved a supplemental application for Risedronate Sodium submitted by Sun Pharmaceutical Industries Inc.

• FDA approval · 2023-11-20
  FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LYLLANA (estradiol) from Amneal Pharmaceuticals LLC (ANDA 211396).

• FDA approval · 2023-11-16
  FDA Approved: TERIPARATIDE — Supplemental Application (Alvogen, Inc.)

  The FDA approved a supplemental application for teriparatide submitted by Alvogen, Inc.

• FDA approval · 2023-11-14
  FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…

• FDA approval · 2023-10-19
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for ibandronate sodium from Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-10-02
  FDA Approved: ANGELIQ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Angeliq (drospi renone and estradiol) from Bayer, updating labeling for postmenopausal indicatio…

• FDA approval · 2023-09-06
  FDA Approved: ESTRADIOL — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original application for a generic Estradiol product.

• FDA approval · 2023-06-23
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for ibandronate sodium submitted by Apotex Corp as part of an ANDA, representing a regulatory update…

• FDA approval · 2023-06-06
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, enabling the approved generic formulation to b…

• FDA approval · 2023-02-15
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for ibandronate sodium submitted by Bionpharma Inc. under ANDA078998.

• FDA approval · 2023-01-31
  FDA 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 for use as a generic product …

• FDA approval · 2022-12-19
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  FDA approved a supplemental application for TYMLOS (abaloparatide) submitted by Radius Health, Inc.

• FDA approval · 2022-12-06
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) submitted by Wyeth Pharmaceuticals (Pfizer) to update…

• FDA approval · 2022-10-11
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for raloxifene hydrochloride from Amneal Pharmaceuticals LLC, authorizing a regulatory change under …

• FDA approval · 2021-11-15
  FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for CLIMARA PRO, the estradiol/levonorgestrel transdermal patch from Bayer HealthCare Pharmaceutical…