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Testosterone News (Page 2)
FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism
EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) – Antares Pharma, Inc., (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration g...
FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
March 27, 2019 – The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have...
FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
EWING, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) – Antares Pharma, Inc. (NASDAQ:ATRS) today announced the approval of Xyosted (testosterone enanthate) injection by the U.S. Food and Drug Administration...
FDA Medwatch Alert: Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence
ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from...
FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.] ...
FDA Medwatch Alert: Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
[Posted 06/20/2014] ISSUE: FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning ...
Upsher-Smith Receives Final NDA Approval For Vogelxo (testosterone) Gel
Maple Grove, MN – June 4, 2014 – Upsher-Smith Laboratories, Inc., today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (ND...
FDA Approves Natesto (testosterone) Nasal Gel to Treat Men with Low Testosterone
TORONTO (May 28, 2014) – Trimel Pharmaceuticals Corporation (TSX: TRL) announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly C...
FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy
DUBLIN, March 6, 2014 /PRNewswire/ – Endo International plc announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of Aveed...
FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
[Posted 01/31/2014] ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to...
FDA Medwatch Alert: University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance
ISSUE: University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, ...
FDA Medwatch Alert: Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
[Posted 05/30/2013] ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that ...
BioSante Pharmaceuticals Announces FDA Approval for Male Testosterone Gel
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb 15, 2012 - BioSante Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Bio-T-Gel, which is licensed by...
Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
CHADDS FORD, Pa., Dec. 29, 2010 /PRNewswire via COMTEX/ --Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Fortesta Gel for the treatment of low...
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