World’s First Testosterone Nasal Gel Now Available on U.S. Market
Entering the world of testosterone treatments is its first and only nasal gel, which is now available on the U.S. market for males with abnormally low levels of the hormone.
According to reports, the medication is called NATESTO and became commercially available on March 16, 2015 after being approved last year by the U.S. Food and Drug Administration (FDA) for congenital and acquired primary hypogonadism and other conditions associated with an absence or deficiency of testosterone. The drug is manufactured by Endo Pharmaceuticals, a company based in Ireland and acts as a subsidiary of Endo International Plc. According to a press release announcing NATESTO, officials released the following statement: “With testosterone gels, implantable testosterone pellets, a long-acting injectable, and now an intranasal gel, Endo offers healthcare professionals a broad range of delivery options to appropriately raise testosterone levels that help meet the individual needs of men living with hypogonadism.”
FDA Orders Adjustment on Labeling for Testosterone Treatments
NATESTO’s entrance into the U.S. market comes a week after the FDA announced its most significant warning about testosterone treatments, in which they ordered manufacturers to adjust the warning labels on their products to adequately warn about their lack of effectiveness in treating conditions other than hypogonadism. According to the federal agency’s alert on March 3, 2015, hormone-raising medications similar to AndroGel, Testim, AndroDerm and other products are not proven safe and effective in men seeking to remedy low libido, sexual dysfunction, fatigue and other common symptoms of aging. They may also increase a patient’s risk for sustaining heart attacks, strokes, sudden cardiac death and other life-threatening issues.
This was the FDA’s first testosterone warning to follow a meeting in September 2014 that concluded in a 20-1 vote from advisers congregated by the agency that labeling on these and several other medications should be altered to highlight certain information regarding their safety and effectiveness.
In January 2014, the FDA first warned about testosterone medications after a study published that previous November in JAMA: Internal Medicine found an increased risk of cardiovascular injuries in testosterone users aged 65 and older, and all younger men with a pre-existing history of heart disease.
Nearly 1,200 testosterone lawsuits involving AndroGel, Testim and other products have also been filed in a federal multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of Illinois.
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