Hyperprolactinemia

• FDA approval · 2008-07-30
  FDA Approved: BROMOCRIPTINE MESYLATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Zydus Pharmaceuticals USA Inc.'s generic bromocriptine mesylate product under an Original Application (ANDA). Bromocriptine mes…

• FDA approval · 2008-06-04
  FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)

  FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC.

• FDA approval · 2007-12-19
  FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for cabergoline submitted by Mylan Pharmaceuticals Inc., authorizing the continued approval of a gen…

• CLINICAL_TRIALS trial_result · 2007-10-10
  Clinical Trial Update: Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia [Phase 4]

  Phase 4 clinical trial update investigating reversal of antipsychotic-induced side effects, including hyperprolactinemia, weight gain, hyper…

• FDA approval · 2007-03-07
  FDA Approved: CABERGOLINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved the original application for cabergoline (generic) by Teva Pharmaceuticals USA, Inc., marking approval of a generic cabergoline…

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• CLINICAL_TRIALS trial_result · 2007-02-16
  Clinical Trial Update: Characterization of Macroprolactinemia

  A completed study that characterizes macroprolactinemia, focusing on the abnormal forms of prolactin.

• FDA approval · 2007-01-25
  FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)

  The FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC, potentially updating labeling and/or ind…

• FDA approval · 2006-12-12
  FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for cabergoline filed by Mylan Pharmaceuticals Inc., updating the product's approval status.

• FDA approval · 2006-08-15
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approval of a supplemental application for a generic bromocriptine mesylate product by Mylan Pharmaceuticals Inc.