Osteoporosis

• FDA approval · 2018-10-17
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for TYMLOS (abaloparatide) from Radius Health, Inc.

• FDA approval · 2018-06-29
  FDA Approved: ZOLEDRONIC ACID — Original Application (Gland Pharma Limited)

  The FDA approved an Original Application for a generic zoledronic acid product by Gland Pharma Limited.

• FDA approval · 2018-06-20
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for TYMLOS (abaloparatide) by Radius Health, Inc. This action reflects an approved supplemental …

• FDA approval · 2018-05-18
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for Prolia (denosumab) submitted by Amgen, related to the drug's labeling/indication via a supplemen…

• FDA approval · 2018-04-06
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ibandronate sodium from Mylan Institutional LLC, granting approval of a generic ibandronate prod…

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• FDA approval · 2018-01-04
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for PROLIA (denosumab) filed by Amgen, Inc., signaling regulatory action related to the product'…

• FDA approval · 2017-10-31
  FDA 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…

• FDA approval · 2017-07-21
  FDA Approved: ESTRADIOL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc. for Estradiol as a new generic product under an Original Application (ANDA206388).

• FDA approval · 2017-07-07
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc.

• FDA approval · 2017-04-18
  FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for alendronate sodium tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.

• FDA approval · 2017-02-02
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for zoledronic acid submitted by Sagent Pharmaceuticals, resulting in an approved labeling change. Z…

• FDA approval · 2016-12-30
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  FDA approved Radius Health's supplemental application for BINOSTO (alendronate sodium), resulting in changes to the product labeling.

• 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.

• FDA approval · 2016-08-05
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc., signaling an approved modification to its label…

• FDA approval · 2016-07-14
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…

• FDA approval · 2016-04-08
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for alendronate sodium filed by Aurobindo Pharma Limited (ANDA 090124).

• FDA approval · 2016-03-29
  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. This action indicates regula…

• FDA approval · 2016-03-25
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for zoledronic acid filed by Sagent Pharmaceuticals.

• FDA approval · 2016-03-11
  FDA 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…

• FDA approval · 2016-02-12
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (EXELAN PHARMACEUTICALS INC.)

  FDA approved a supplemental application for alendronate sodium from Exelan Pharmaceuticals Inc. under the ANDA program.

• FDA approval · 2016-01-26
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for Binosto (alendronate sodium) from Radius Health. The action results in an update to the prod…

• FDA approval · 2016-01-11
  FDA Approved: EVISTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Evista to expand its labeling. The update adds a use for reducing breast cancer risk in postmeno…

• FDA approval · 2015-12-15
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for risendronate sodium submitted by Apotex Corp., resulting in an approved change to the marketed p…

• FDA approval · 2015-12-09
  FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for risendronate sodium (generic risendronate) from Macleods Pharmaceuticals Limited.