FDA grants final approval to oral testosterone undecanoate for men with hypogonadism
The FDA has given final approval for an oral testosterone undecanoate therapy for men with a deficiency or absence of endogenous testosterone or hypogonadism, according to an industry press release.
Oral testosterone undecanoate (Tlando, Antares Pharma) was approved for use by men aged 18 years or older with primary or hypgonadotropic hypogonadism, either congenital or acquired. As Healio previously reported, the FDA had granted tentative approval for Antares Pharma’s oral testosterone undecanoate in December 2020, but the drug was not eligible for final approval and marketing in the U.S. until the expiration of an exclusivity period previously granted to Clarus Therapeutics for oral testosterone undecanoate (Jatenzo), which expired March 27, 2022. The commercial launch of Tlando is expected in the second quarter of 2022.
“We are excited with the opportunity to commercialize Tlando and reinforce our commitment to the testosterone replacement therapy market,” Joe Renda, senior vice president of commercial for Antares Pharma, said in the release. “With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options. We believe Tlando’s oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options.”
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