Antares wins full FDA approval for testosterone replacement therapy

Mar. 29, 2022 8:04 AM ETHalozyme Therapeutics, Inc. (HALO), LPCN, CRXTBy: Dulan Lokuwithana, SA News Editor5 Comments

Headquarters of US Food and Drug Administration (FDA)

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  • The commercial-stage pharma company, Antares Pharma (NASDAQ:ATRS), announced that the U.S. Food and Drug Administration (FDA) granted the final approval for TLANDO (testosterone undecanoate).
  • An oral form of testosterone replacement therapy, TLANDO, is indicated for adults with hypogonadism, a condition characterized by deficiency or absence of testosterone hormone in the body.
  • The company plans to launch the drug in the second quarter of this year, Chief Executive Robert F. Apple said, highlighting the company’s recent expansion of the sales function.
  • “We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO,” he said.
  • Antares (ATRS) has an exclusive license agreement with Lipocine (NASDAQ:LPCN) for TLANDO.
  • It was granted tentative approval by the FDA in late 2020. The expiration of the exclusivity period granted for a rival therapy from Clarus Therapeutics (NASDAQ:CRXT) will lead to the full approval for TLANDO in March, Antares (ATRS) said in its latest 10-K filing.

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