Glucocorticoid-induced Osteoporosis

• FDA approval · 2026-04-15
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Aurobindo Pharma Limited.

• FDA approval · 2026-02-03
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for alendronate sodium, updating the approved product under the ANDA.

• FDA approval · 2025-12-12
  FDA Approved: TERIPARATIDE — Original Application (Amphastar Pharmaceuticals, Inc.)

  FDA approved Amphastar Pharmaceuticals' original application for a generic teriparatide product.

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

  FDA approves Apotex Corp.'s supplemental application for a generic teriparatide product.

• FDA approval · 2024-11-06
  FDA Approved: TERIPARATIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Teriparatide (teriparatide), enabling marketing of a generic teriparatide product. This act…

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• FDA approval · 2024-09-27
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ALENDRONATE SODIUM by Aurobindo Pharma Limited (generic).

• 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 · 2023-12-18
  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 · 2023-06-07
  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 · 2023-01-31
  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 · 2021-09-07
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories. This action relates to a supplemental approva…

• FDA approval · 2020-11-16
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, expanding or updating the drug's regulatory statu…

• FDA approval · 2020-10-13
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc., supporting a label expansion/updated …

• FDA approval · 2020-08-06
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Risendronate Sodium from Aurobindo Pharma Limited.

• FDA approval · 2020-06-08
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  FDA approves a supplemental application for BINOSTO (alendronate sodium) submitted by Radius Health, Inc.

• FDA approval · 2020-04-06
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories under NDA 021318.

• FDA approval · 2019-10-03
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories.

• FDA approval · 2019-08-19
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2019-07-09
  FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industires Inc.)

  FDA approved Sun Pharmaceutical's risendronate sodium as an original application for a generic product, with indications for osteoporosis-re…

• FDA approval · 2019-02-15
  FDA Approved: RISEDRONATE SODIUM — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd)

  FDA approved the generic drug risedronate sodium under an Original Application, expanding access to this bisphosphonate for osteoporosis- an…

• FDA approval · 2017-04-28
  FDA 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…

• FDA approval · 2016-11-29
  FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original ANDA for a generic rise-dronate sodium product (RISEDRONATE SODIUM). The approved i…

• FDA approval · 2016-10-21
  FDA Approved: RISEDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original ANDA for risedronate sodium, a generic osteoporosis treatment, enabling market entry.