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FDA removes Boxed Warning for testosterone products after TRAVERSE trial benefits Lipocine
Lipocine Inc.
- FDA removes Boxed Warning on cardiovascular risk for all testosterone products based on TRAVERSE trial.
- Label changes include adding TRAVERSE results and retaining Limitation of Use for age-related hypogonadism.
- FDA requires product-specific blood pressure information from ABPM studies on all testosterone labels.
- Lipocine CEO says label changes beneficial to approved TLANDO and pipeline candidates for obesity and liver disease.