Osteoporosis

• 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 · 2024-03-05
  FDA Approved: WYOST — Original Application (Sandoz Inc)

  FDA approved WYOST (denosumab) from Sandoz Inc under an original Biologics License Application.

• FDA approval · 2024-01-19
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for Prolia (denosumab) from Amgen.

• FDA approval · 2024-01-08
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for risendronate sodium by Sun Pharmaceutical Industries, expanding or modifying its labeling un…

• 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 …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2023-11-16
  FDA Approved: TERIPARATIDE — Supplemental Application (Alvogen, Inc.)

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

• FDA approval · 2023-11-16
  FDA Approved: TERIPARATIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for generic teriparatide (Teriparatide) to treat osteoporosis.

• FDA approval · 2023-11-16
  FDA Approved: TERIPARATIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s generic teriparatide through an original ANDA for use in osteoporosis.

• FDA approval · 2023-08-24
  FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).

• 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 · 2023-06-07
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for ibandronate sodium from Macleods Pharmaceuticals Limited. This approval constitutes a supplement…

• FDA approval · 2023-06-07
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for risendronate sodium from Macleods Pharmaceuticals Limited.

• 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 · 2023-06-05
  FDA Approved: ZOLEDRONIC ACID — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for zoledronic acid, enabling a generic IV bisphosphonate product. This mark…

• FDA approval · 2023-05-12
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for risendronate sodium (a generic osteoporosis medication) under ANDA090877.

• FDA approval · 2023-05-11
  FDA Approved: ALENDRONATE SODIUM — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' Original Application (ANDA) for alendronate sodium (ALENDRONATE SODIUM).

• FDA approval · 2023-04-28
  FDA Approved: ESTRADIOL VALERATE — Original Application (Xiromed, LLC)

  The FDA approved Xiromed, LLC's Estradiol Valerate as an original-application generic (ANDA 216656), authorizing its marketing for approved …

• FDA approval · 2023-03-08
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for zoledronic acid from Fresenius Kabi USA, LLC.

• FDA approval · 2023-03-07
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for zoledronic acid submitted by Mylan Institutional LLC.

• 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 · 2022-04-05
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for Zoledronic acid submitted by Sagent Pharmaceuticals, updating regulatory labeling per the su…

• FDA approval · 2022-02-22
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ibandronate sodium filed by Aurobindo Pharma Limited, approving the generic product under the AN…