Third time unlucky: Lipocine's latest quest to market their oral testosterone drug snubbed again by FDA
Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.
The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.
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