Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-02-18FDA Approved: METHYLTESTOSTERONE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original application for methyltestosterone, making a generic methyltestosterone product available.
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FDA approval · 2021-12-23FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for testosterone cypionate from Cipla USA Inc., updating the approval of this generic product.
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FDA approval · 2021-11-09FDA Approved: TESTOSTERONE GEL, 1% — Original Application (Encube Ethicals, Inc.)
The FDA approved Encube Ethicals, Inc.'s TESTOSTERONE GEL, 1% as an Original Application (ANDA), establishing a generic testosterone replace…
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FDA approval · 2021-08-20FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone) from Endo USA, Inc., updating labeling as part of the supplemental submiss…
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FDA approval · 2021-08-16FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. to update labeling related to its use for t…
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FDA approval · 2021-07-13FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)
The FDA approved a supplemental application for TESTOSTERONE CYPIONATE by Padagis US LLC. This action relates to changes approved for this g…
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FDA approval · 2021-06-28FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. The action updates the product label and/or…
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CLINICAL_TRIALS trial_result · 2021-06-24Clinical Trial Update: Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men [Phase 2]
Phase 2 pharmacokinetic study of oral testosterone ester formulations in men with hypogonadism has completed with results posted.
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FDA approval · 2021-06-14FDA Approved: TESTOSTERONE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' Original Application for TESTOSTERONE, a generic testosterone product.
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CLINICAL_TRIALS trial_result · 2021-05-10Clinical Trial Update: Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
A completed clinical trial studying perioperative hypogonadism in men undergoing radical cystoprostatectomy for bladder cancer with results …
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CLINICAL_TRIALS trial_result · 2021-04-29Clinical Trial Update: A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males [Phase 1]
Phase 1 bioequivalence study of testosterone cypionate in hypogonadal males has been completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-04-28Clinical Trial Update: Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency [Phase 2, Phase 3]
A study investigating testosterone replacement therapy in aging men with androgen deficiency has completed Phase 2 and Phase 3.
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FDA approval · 2021-03-03FDA Approved: TESTOSTERONE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic's original application for testosterone, a generic product.
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CLINICAL_TRIALS trial_result · 2020-12-11Clinical Trial Update: Pharmacokinetic Study to Determine Time to Steady-state [Phase 2]
Phase 2 pharmacokinetic study to determine time to steady-state; completed with posted results.
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FDA approval · 2020-11-30FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
The FDA has approved a supplemental application for TESTIM (testosterone) submitted by Endo USA, Inc.
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FDA approval · 2020-10-29FDA Approved: TESTOSTERONE ENANTHATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for testosterone enanthate submitted by Hikma Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2020-09-16Clinical Trial Update: Testosterone Therapy in Hypogonadal Men Treated With Opioids [Phase 4]
Phase 4 clinical trial investigating testosterone therapy in men with hypogonadism treated with opioids has completed.
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CLINICAL_TRIALS trial_result · 2020-09-11Clinical Trial Update: Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen [Phase 3]
Phase 3 trial investigating testosterone plus dutasteride versus placebo effects on muscle strength, body composition, and metabolism in tra…
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CLINICAL_TRIALS trial_result · 2020-08-31Clinical Trial Update: Lifestyle Intervention and Testosterone Replacement in Obese Seniors [Phase 3]
Phase 3 trial assessing lifestyle intervention with testosterone replacement in obese seniors; results posted after completion.
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FDA approval · 2020-06-30FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc.
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EMA withdrawal · 2020-06-23EMA Withdrawn: Fertavid (follitropin beta) — Merck Sharp & Dohme B.V.
Fertavid (follitropin beta) has been withdrawn from EMA status by Merck Sharp & Dohme B.V. with no remaining active medicinal products.
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CLINICAL_TRIALS trial_result · 2020-06-18Clinical Trial Update: Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors [Phase 3]
Phase 3 trial update on transdermal testosterone and/or monthly vitamin D and their effect on fall risk in pre-frail hypogonadal seniors; st…
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FDA approval · 2020-04-30FDA Approved: VOGELXO — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approves a supplemental application for Vogelxo (testosterone) by Upsher-Smith Laboratories, updating the labeling for this testosterone…
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FDA approval · 2020-04-16FDA Approved: TESTOSTERONE — Original Application (Xiromed, LLC)
FDA approved Xiromed, LLC's original application for a generic testosterone product.
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FDA approval · 2020-03-13FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED, a testosterone undecanoate product, submitted by Endo USA, Inc.