Central Precocious Puberty
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-01-20FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc. The action expands the product's…
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FDA approval · 2014-10-10FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals.
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CLINICAL_TRIALS trial_result · 2014-08-04Clinical Trial Update: The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty [Phase 4]
A Phase 4 trial evaluating the efficacy and safety of Luphere Depot Inj. 3.75mg (leuprolide acetate) in central precocious puberty has compl…
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FDA approval · 2014-07-18FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approves a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval updates th…
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FDA label_change · 2014-05-30FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. This notice relates to regulatory ac…
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FDA approval · 2014-03-14FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
The FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) submitted by Verity Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2013-12-10Clinical Trial Update: Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty [Phase 3]
A completed Phase 3 safety-extension trial evaluated leuprolide acetate (Lupron Depot) for central precocious puberty, with results posted i…
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FDA approval · 2013-06-19FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., expanding its regulatory approval.
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FDA approval · 2013-05-14FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) by AbbVie Inc., related to its pediatric formulation. The …
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FDA approval · 2013-04-02FDA 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…
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FDA approval · 2013-02-27FDA 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…
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CLINICAL_TRIALS research · 2013-02-27Clinical Trial Update: First-Voided Urinary LH vs. GnRH-stimulation in Differentiating Slowly- From Rapidly Progressive-Precocious Puberty [NA]
The update discusses a clinical trial evaluating first-voided urinary LH versus GnRH-stimulation to differentiate slowly from rapidly progre…
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FDA approval · 2013-02-08FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) by URONOVA Pharmaceuticals.
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FDA label_change · 2013-01-25FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals, resulting in labeling changes for th…
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FDA approval · 2012-04-05FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc.
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FDA approval · 2012-01-23FDA 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 · 2011-10-30FDA 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 …
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FDA approval · 2011-10-08FDA 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…
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FDA approval · 2011-08-15FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie.
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FDA approval · 2011-06-14FDA 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.
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FDA approval · 2011-04-26FDA 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…
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FDA approval · 2011-04-08FDA 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…
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FDA label_change · 2011-04-08FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
The FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC.
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FDA approval · 2011-03-28FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc. for Leuprolide acetate (ANDA 074728).
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CLINICAL_TRIALS trial_result · 2011-02-09Clinical Trial Update: A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty [Phase 3]
This update reports the completion of a Phase 3 trial evaluating two quarterly dosing regimens of leuprolide (11.25 mg and 30 mg) for centra…