Central Precocious Puberty
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-11-14FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) from Avyxa Pharma, LLC. This action updates the product’s lab…
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FDA approval · 2024-10-17FDA Approved: FENSOLVI — Supplemental Application (TOLMAR Inc.)
FDA approved a supplemental application for FENSOLVI (leuprolide acetate) filed by Tolmar Inc. This action updates the product labeling.
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FDA approval · 2024-10-17FDA Approved: LEUPROLIDE ACETATE — Original Application (UBI Pharma Inc.)
FDA approves Leuprolide acetate under an Original Application, establishing a generic version by UBI Pharma Inc. for the listed indications.
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CLINICAL_TRIALS trial_result · 2024-08-01Clinical Trial Update: Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. [Phase 3]
A Phase 3 trial evaluating the efficacy and safety of a 3-month formulation of triptorelin in Chinese children with central precocious puber…
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CLINICAL_TRIALS research · 2024-07-05Clinical Trial Update: Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP [Phase 4]
Phase 4 clinical trial comparing a 3-month triptorelin formulation to a 1-month formulation in Central Precocious Puberty to assess efficacy…
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CLINICAL_TRIALS trial_result · 2024-05-28Clinical Trial Update: A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. [Phase 3]
A Phase 3 study evaluating the efficacy and safety of a 6-month formulation of triptorelin in pediatric patients with Central Precocious Pub…
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FDA label_change · 2024-01-23FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals to modify the drug's labeling.
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FDA approval · 2023-12-04FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie, updating the product's label under a supplemental…
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FDA approval · 2023-12-04FDA 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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CLINICAL_TRIALS trial_result · 2023-09-06Clinical Trial Update: Evaluate the Efficacy and Safety of DWJ108J [Phase 3]
A Phase 3 clinical trial update for DWJ108J in Central Precocious Puberty is listed, with unknown status.
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CLINICAL_TRIALS trial_result · 2023-05-16Clinical Trial Update: A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP) [Phase 3]
Phase 3 study evaluating Leuprolide acetate 45 mg, a 6-month formulation, in children with central precocious puberty has completed and resu…
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FDA approval · 2023-04-14FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) filed by AbbVie to expand its pediatric indication.
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FDA approval · 2023-02-28FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
The FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) submitted by Avyxa Pharma, LLC.
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FDA approval · 2022-11-25FDA Approved: FENSOLVI — Supplemental Application (TOLMAR Inc.)
FDA approved Tolmar Inc.'s supplemental application for FENSOLVI (leuprolide acetate). This action updates the original approval via a suppl…
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FDA approval · 2022-10-28FDA Approved: LEUPROLIDE ACETATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' original ANDA for Leuprolide acetate, a generic version of Lupron.
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FDA approval · 2022-06-06FDA Approved: LEUPROLIDE ACETATE — Original Application (Eugia US LLC)
The FDA approved Eugia US LLC's generic Leuprolide Acetate under an Original Application (ANDA 212963), making a generic version of this med…
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FDA approval · 2022-04-22FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for LUPRON DEPOT-PED (Leuprolide acetate) from AbbVie Inc., supporting its pediatric use. This r…
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FDA approval · 2022-04-22FDA Approved: FENSOLVI — Supplemental Application (TOLMAR Inc.)
FDA approved a supplemental application for FENSOLVI (leuprolide acetate) from Tolmar Inc., expanding its labeling.
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FDA approval · 2022-04-22FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc. The action concerns the drug’s labeling/ind…
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FDA approval · 2021-11-12FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) by AbbVie, updating its labeling for pediatric use.
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FDA approval · 2021-08-13FDA Approved: LEUPROLIDE ACETATE — Original Application (NorthStar RxLLC)
FDA approved the Leuprolide acetate original application (ANDA213829) for a generic version, issued to NorthStar RxLLC.
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FDA approval · 2021-03-11FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) to update its labeling for pediatric use.
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FDA approval · 2021-02-01FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Leuprolide acetate submitted by Sandoz Inc. This action approves changes under the generic d…
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CLINICAL_TRIALS trial_result · 2021-01-08Clinical Trial Update: Histrelin Subcutaneous Implant in Children With Central Precocious Puberty [Phase 3]
Phase 3 trial update for a histrelin subcutaneous implant in children with central precocious puberty, results posted after completion.
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CLINICAL_TRIALS trial_result · 2021-01-06Clinical Trial Update: Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls [Phase 3]
Phase 3 clinical trial validating the triptorelin test for diagnosing central precocious puberty in girls has completed.