Central Precocious Puberty

• FDA approval · 2013-04-02
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., representing an additional regulatory acti…

• FDA approval · 2013-02-27
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval pertains t…

• FDA approval · 2013-02-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) by URONOVA Pharmaceuticals.

• FDA approval · 2012-04-05
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc.

• FDA approval · 2012-01-23
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Lupron Depot (leuprolide acetate) from AbbVie, resulting in an updated approval and labeling for…

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• FDA approval · 2011-10-30
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., resulting in updated labeling for the …

• FDA approval · 2011-10-08
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie Inc., updating the product labeling to support…

• FDA approval · 2011-08-15
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie.

• FDA approval · 2011-06-14
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) by AbbVie, expanding its approved indications and labeling.

• FDA approval · 2011-04-26
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide Acetate from Sun Pharmaceutical Industries, resulting in changes to the product's…

• FDA approval · 2011-04-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) filed by Uronova Pharmaceuticals. This action approves the supplem…

• FDA approval · 2011-03-28
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc. for Leuprolide acetate (ANDA 074728).

• 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…

• 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…

• 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 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).