Central Precocious Puberty
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Sign up freeTop drugs studied for this disease
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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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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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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 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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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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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…
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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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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 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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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 …