FDA declines to approve Lipocine's testosterone drug for third time

[November 11, 2019]  (Reuters) - The U.S. Food and Drug Administration on Monday declined to approve Lipocine Inc's oral drug to treat a condition that results in lower production of sex hormone, the third regulatory setback for the drug in over three years.

The company said it received a letter from the FDA in which the regulator indicated it could not approve its application in its present form and noted that the company's trial did not meet three secondary goals.

The FDA had first declined to approve the drug, Tlando, in 2016 and then again in 2018.

(Reporting by Trisha Roy and Tamara Mathias in Bengaluru; Editing by Saumyadeb Chakrabarty)

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