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Halozyme Launches the Testosterone Replacement Tlando
Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.
Halozyme Therapeutics has launched Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Developed by Antares Pharma, Tlando does not require dose titration and was approved by the FDA on March 28, 2022.
Helen Torley, M.B. Ch. B.
“Tlando provides patients with a convenient oral dosing option for testosterone replacement therapy. The launch of Tlando represents our second testosterone replacement therapy product, following the 2018 launch of Xyosted (testosterone enanthate), a weekly subcutaneous auto-injector,” Helen Torley, M.B. Ch. B., president and chief executive officer of Halozyme, said in a press release.
Related: FDA Approves Oral Testosterone Replacement Tlando
In May 2022, Halozyme completed its acquisition of Antares, a transaction valued at about $960 million. Halozyme executives said in April when the acquisition was announced that Antares’ auto injector platform and specialty commercial business augment Halozyme’s strategy. Halozyme expects to build on Antares existing platform technology to drive revenue opportunities with additional intellectual property protections for Antares technology in place beyond 2030.
Male hypogonadism is an endocrine disorder in which the body fails to produce enough testosterone. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes.
FDA Actions in Brief December 2012
December 31st 2012Recent FDA Approvals (through December 2012) related to (Bedaquiline, Janssen, Oseltamivir, Genetech, Apixaban, Bristol-Myers Squibb, Lomitapide, Aegerion, Varicella zoster immune globulin preparation, Cangene, Teduglutide, NPS Pharmaceuticals, Pasireotide diaspartate, Novartis, Ponatinib, ARIAD Pharmaceuticals, Influenza virus vaccine, GlaxoSmithKline, Raxibacumab, Crofelemer, Salix, Cabozantinib, Exelixis)
