Antares Pharma’s Tlando Receives the US FDA’s Approval for the Treatment of Testosterone Replacement Therapy
Shots:
- The US FDA has approved Tlando for TRT associated with an absence of endogenous testosterone or hypogonadism in adult males. The therapy is expected to be available in Q2’22 to provide a complementary treatment option to patients & clinicians
- The approval was based on a P-III study to evaluate Tlando (225mg, PO, BID for ~24 days) in 95 adult male patients which showed 80% achieved a 24hr. avg. serum testosterone concentration & had a maximum total testosterone concentration threshold ≤1620ng/dL b/w 1944/2700/2700ng/dL (82%/5%/0%), respectively.
- The company continues to support patient-centric care for different treatment options with an expanded commercial footprint
Ref: Globe Newswire | Image: Antares
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