Central Precocious Puberty

• FDA label_change · 2011-01-14
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for ZOLADEX (goserelin) from TerSera Therapeutics LLC. The approval includes changes to the product …

• FDA approval · 2010-10-05
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) by URONOVA PHARMACEUTICALS, INC.

• FDA approval · 2010-08-30
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie, updating the label for pediatric use in centr…

• CLINICAL_TRIALS trial_result · 2010-07-20
  Clinical Trial Update: Study of Lupron Depot In The Treatment of Central Precocious Puberty [Phase 3]

  Phase 3 trial of Lupron Depot (leuprolide acetate) for central precocious puberty has completed with results posted in 2010.

• FDA approval · 2009-06-24
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie, updating the label for pediatric use of the d…

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• FDA approval · 2009-03-09
  FDA Approved: LEUPROLIDE ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Leuprolide acetate from Sun Pharmaceutical Industries as an original application (generic) for multiple hormone-related indicat…

• FDA approval · 2008-07-31
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie, related to pediatric use.

• FDA approval · 2008-07-02
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., supporting an expanded/updated labelin…

• FDA label_change · 2007-11-21
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) submitted by Endo USA, Inc., resulting in changes to the produc…

• FDA approval · 2007-11-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC., signaling an expanded/updated …

• FDA approval · 2007-05-03
  FDA Approved: SUPPRELIN LA — Original Application (Endo USA, Inc.)

  FDA approved SUPPRELIN LA (histrelin acetate) from Endo USA, Inc. under an Original NDA (NDA 022058).

• CLINICAL_TRIALS trial_result · 2007-02-22
  Clinical Trial Update: Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children [Phase 4]

  This Phase 4 clinical trial update investigates how genetic and environmental factors influence growth rate in children with Central Precoci…