Repros Therapeutics Inc said the U.S. health regulators asked the company to propose a label that better defines the population of individuals who will benefit from the use its male-infertility drug Androxal, sending its shares soaring.
The company had previously tried to pursue a hypogonadism label for the drug but was unable to reach an agreement with the U.S. Food and Drug Administration in 2007 regarding a clinical path for the drug.
Repros said the FDA also requested the company to conduct a literature review of the incidence of infertility associated with the use of exogenous testosterone.
If the submitted data is approved, no additional meeting regarding the label may be required, the company said.
Story from Reuters.
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