Hypercalcemia Due to Parathyroid Carcinoma

• FDA approval · 2023-12-08
  FDA Approved: CINACALCET — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare’s generic cinacalcet product. The approval confirms continued market availabil…

• FDA approval · 2023-07-28
  FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's supplemental application for Cinacalcet, granting approval of a generic cinacalcet product.

• FDA approval · 2021-12-02
  FDA Approved: CINACALCET HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals' cinacalcet hydrochloride generic under an Original Application (ANDA), enabling a generic version of ci…

• FDA approval · 2020-12-04
  FDA Approved: CINACALCET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Cinacalcet from Sun Pharmaceutical Industries, enabling an additional regulatory action for the …

• FDA approval · 2020-12-04
  FDA Approved: CINACALCET — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Cinacalcet from Ascend Laboratories, LLC, granting approval of a generic cinacalcet product unde…

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• FDA approval · 2020-09-18
  FDA Approved: CINACALCET — Original Application (Dr. Reddys Laboratories Inc)

  FDA approval of Dr. Reddy's Laboratories' generic cinacalcet tablets (ANDA 208368) as an original application, with indications for secondar…

• FDA approval · 2020-05-15
  FDA Approved: CINACALCET — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare's generic cinacalcet (Cinacalcet) under an original application, expanding access to treatment for two approv…

• FDA approval · 2020-05-14
  FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental ANDA for Cinacalcet from Aurobindo Pharma Limited, expanding access to a generic version of the drug.

• FDA approval · 2020-04-02
  FDA Approved: CINACALCET — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for cinacalcet under ANDA 208915. The approval authorizes the continued marketing of …

• FDA approval · 2019-05-17
  FDA Approved: CINACALCET — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic cinacalcet product from Ascend Laboratories for treating secondary hyperparathyroidism in adults with chronic kidney …

• FDA approval · 2018-10-11
  FDA Approved: CINACALCET — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved cinacalcet (Sun Pharmaceutical) via an original application; the generic CINACALCET is approved for secondary hyperparathyroidi…

• FDA approval · 2008-02-28
  FDA Approved: SENSIPAR — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for SENSIPAR (cinacalcet hydrochloride) from Amgen.