June 9, 2014 — Upsher-Smith Laboratories announced that they have received approval for Vogelxo, a testosterone gel product that is used to treat male hypogonadism (low testosterone).
Vogelxo is sold in tubes that contain 5-g of gel and 50-mg of testosterone. The product will also be sold in 2-count cartons with 88-g metered-dose pumps, with each pump delivering 12.5-mg of testosterone. The gel is applied to the skin and testosterone is absorbed directly into the bloodstream.
The approval comes amid a safety investigation launched by the U.S. Food and Drug Administration (FDA) earlier this year. The agency is concerned about several recent studies linking testosterone replacement therapy with an increased risk of blood clots, heart attack, stroke, pulmonary embolism, and death. The most recent study, published in PLOS One in January, found a doubled risk of heart attack for older men in poor health who used testosterone gel.
Earlier this month, federal judges ordered that about 100 lawsuits involving AndroGel and other testosterone products will be centralized in a Multi-District Litigation (MDL) in Illinois. The manufacturer of AndroGel, AbbVie Inc., is accused of spending $80 million to promote testosterone gel as a “cure-all” for normal symptoms of aging, including fatigue, low sex drive, depressed mood, sagging muscles, and more.
In the last few months, the FDA has approved several new testosterone replacement products, including Aveed and Natesto. It is no wonder these gels, creams, patches, injections, and other products are flooding the market. Last year, AndroGel alone had sales exceeding $1 billion.