Central Precocious Puberty
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-06-02Clinical Trial Update: Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty [Phase 4]
A Phase 4 clinical trial update on Leuprorelin acetate DPS (Leuplin DPS) for monthly/quarterly treatment in central precocious puberty has c…
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CLINICAL_TRIALS trial_result · 2020-05-20Clinical Trial Update: Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty [Phase 3]
Phase 3 trial update for leuprolide acetate injectable suspension in central precocious puberty has completed with results posted.
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FDA approval · 2020-05-01FDA Approved: FENSOLVI — Original Application (TOLMAR Inc.)
FDA approved FENSOLVI (leuprolide acetate) from Tolmar Inc. as an original NDA approval for the treatment of central precocious puberty in p…
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FDA approval · 2020-04-07FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie, updating the label for pediatric use.
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FDA approval · 2020-03-18FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie Inc.
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FDA approval · 2019-11-08FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., signaling regulatory advancement for t…
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CLINICAL_TRIALS trial_result · 2019-10-24Clinical Trial Update: A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
A completed clinical trial evaluating the safety and efficacy of Enantone (leuprorelin) in Chinese participants with central precocious pube…
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CLINICAL_TRIALS trial_result · 2019-07-24Clinical Trial Update: A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants [Phase 4]
Phase 4 trial assessing safety and efficacy of leuprorelin in Chinese participants with central precocious puberty has completed and results…
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FDA approval · 2019-03-04FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie Inc.
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FDA approval · 2019-02-15FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals, resulting in changes to the labeling…
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FDA approval · 2018-12-10FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie, resulting in a labeling update via a supp…
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for leuprolide acetate from Sandoz Inc, authorizing an update related to this product.
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FDA approval · 2017-05-19FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc.
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FDA approval · 2017-05-19FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for LUPRON DEPOT-PED, expanding the label for pediatric use of leuprolide acetate.
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FDA label_change · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Leuprolide acetate from Sun Pharmaceutical Industries, updating the labeling for this generi…
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for leuprolide acetate from Meitheal Pharmaceuticals Inc, related to the existing approval for this …
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FDA approval · 2017-05-19FDA Approved: SYNAREL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Synarel (nafarelin acetate) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2017-01-13FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
The FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA PHARMACEUTICALS, INC., resulting in label…
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CLINICAL_TRIALS trial_result · 2016-11-28Clinical Trial Update: Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate [Phase 4]
A Phase 4 clinical trial analysis examines body mass index in patients with central precocious puberty treated with leuprolide acetate.
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CLINICAL_TRIALS trial_result · 2016-09-30Clinical Trial Update: Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty [Phase 4]
This update notes the completion of a Phase 4 clinical trial evaluating comprehensive diagnosis and treatment for central precocious puberty…
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FDA label_change · 2016-02-29FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. The supplemental action updates the …
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FDA approval · 2016-02-29FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA Pharmaceuticals.
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CLINICAL_TRIALS trial_result · 2015-09-04Clinical Trial Update: Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty [Phase 3]
This Phase 3 trial evaluates the efficacy, safety, and pharmacokinetics of a six-month formulation of triptorelin in children with central p…
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FDA approval · 2015-05-08FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Leuprolide acetate submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2015-04-21FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc. The product is a histrelin acetate impl…