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Testosterone News (Page 2)
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...