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Natesto 2 articles

Sales of testosterone nasal spray to be discontinued in U.S.

Pharmaceutical company Endo is terminating its agreement with Acerus Pharmaceuticals Corporation to market the nasal testosterone treatment NATESTO in the United States, effective June 30, 2016. NATESTO was approved in May 2014 and is the first and only testosterone nasal spray gel sold in the U.S. for the treatment of hypogonadism, a condition in which men do not produce enough testosterone due to injury or disease. The gel is available as a metered dose pump containing 60 actuations. Each pump delivers 5.5mg of testosterone in 0.122g gel. “While we are disappointed with Endo’s previously announced strategic business decision to realign their U.S. ... Read More

FDA approves new warning label for testosterone replacement treatments

The safety labels of prescription testosterone replacement products warning of cardiovascular risks have been updated and approved by the Food and Drug Administration (FDA). The products include gels, patches, topical solutions, nasal sprays and injections. Brand names include: Androderm AndroGel Aveed Axiron Delatestryl Fortesta Natesto Striant Testim Testosterone Gel Vogelxo The new warning is listed under Warnings and Precautions and Adverse Reactions sections, and states, “Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk ... Read More