TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
Halozyme Therapeutics announced the commercial launch of TLANDO (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
"We are delighted to announce the commercial availability of TLANDO and provide 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, a weekly subcutaneous auto-injector. The TLANDO approval and commercial launch demonstrate our continued commitment to developing new drug delivery options for patients," commented Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to expanding our market share in this growing therapeutic category with both XYOSTED and TLANDO."
"Our sales organization is well positioned to leverage its experience and physician relationships established through the commercialization of XYOSTED," said Joe Renda, senior vice president, commercial of Halozyme. "We believe TLANDO's oral formulation and convenient dosing, which requires no titration, are key benefits for physicians and patients."
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