Hypogonadism
📧 Sign up to get email alerts when something new happens for Hypogonadism.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2020-01-30Clinical Trial Update: Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot) [Phase 4]
A Phase 4 pilot trial studied aromatase inhibitors and weight loss in severely obese hypogonadal male veterans; results were completed with …
-
CLINICAL_TRIALS withdrawal · 2019-11-21Clinical Trial Update: Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction [Phase 2, Phase 3]
A clinical trial evaluating testosterone replacement to improve exercise capacity in hypogonadal men after acute myocardial infarction has b…
-
FDA label_change · 2019-11-19FDA Approved: XYOSTED — Supplemental Application (Antares Pharma, Inc.)
FDA approved a supplemental labeling application for XYOSTED (testosterone enanthate) by Antares Pharma, Inc.
-
FDA approval · 2019-11-01FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for testosterone submitted by Actavis Pharma, Inc., updating/expanding the approval for the test…
-
FDA approval · 2019-09-23FDA Approved: TESTOSTERONE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Upsher-Smith's TESTOSTERONE under an original application (ANDA) for testosterone therapy.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2019-09-11Clinical Trial Update: Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). [Phase 3]
Phase 3 dosing validation study of oral testosterone undecanoate (LPCN 1021) completed with results posted in 2019.
-
CLINICAL_TRIALS trial_result · 2019-08-26Clinical Trial Update: Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men [Phase 2]
A Phase 2 clinical trial evaluating the effects of testosterone gel on carbohydrate and lipid metabolism in elderly obese men has completed;…
-
CLINICAL_TRIALS trial_result · 2019-08-12Clinical Trial Update: Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ [Phase 4]
Phase 4 open-label study assessing patient satisfaction and symptom improvement in male hypogonadism treated with Natesto.
-
FDA approval · 2019-06-27FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for TESTOSTERONE from Padagis Israel Pharmaceuticals Ltd.
-
FDA approval · 2019-06-21FDA Approved: TESTOSTERONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for TESTOSTERONE from Amneal Pharmaceuticals NY LLC.
-
FDA approval · 2019-06-21FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for TESTOSTERONE from Actavis Pharma, Inc. under the ANDA pathway.
-
FDA approval · 2019-06-11FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for a generic testosterone product from Actavis Pharma (ANDA205328).
-
FDA approval · 2019-06-04FDA Approved: TESTOSTERONE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)
FDA approved a supplemental application for TESTOSTERONE from Dr. Reddy's Laboratories, authorizing a generic testosterone product to be mar…
-
FDA approval · 2019-06-04FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for TESTOSTERONE submitted by Lupin Pharmaceuticals, Inc., approving changes related to this tes…
-
FDA approval · 2019-06-03FDA Approved: TESTOSTERONE — Supplemental Application (Strides Pharma Science Limited)
FDA approves Strides Pharma Science Limited's supplemental application for TESTOSTERONE.
-
FDA approval · 2019-06-03FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for TESTOSTERONE (testosterone).
-
FDA approval · 2019-06-03FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for TESTOSTERONE by Actavis Pharma, Inc., under ANDA 076737.
-
FDA approval · 2019-05-31FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for TESTOSTERONE submitted by Padagis Israel Pharmaceuticals Ltd.
-
FDA approval · 2019-05-30FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
The FDA approved a supplemental application for AndroGel (testosterone) from ASCEND Therapeutics U.S., LLC.
-
FDA approval · 2019-05-30FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM, a testosterone gel, submitted by Endo USA, Inc., to update its labeling for testosterone…
-
FDA approval · 2019-05-30FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE submitted by Prasco Laboratories. This action approves a modification to the approv…
-
CLINICAL_TRIALS trial_result · 2019-05-16Clinical Trial Update: A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males [Phase 1, Phase 2]
A Phase 1/2a trial evaluating dose response pharmacokinetics of TSX-011 (testosterone undecanoate) in hypogonadal males was terminated, with…
-
FDA approval · 2019-05-10FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone gel) by Endo USA, Inc.
-
FDA approval · 2019-05-10FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE by Prasco Laboratories.
-
FDA approval · 2019-05-10FDA Approved: VOGELXO — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for Vogelxo (testosterone) by Upsher-Smith Laboratories, LLC, approving changes to the product's lab…