Endo International Plc said the US Food and Drug
Administration has approved testosterone
undecanoate (Aveed) injection for the treatment of adult men with
hypogonadism that is associated with a deficiency or absence of the male
Aveed is "indicated to produce serum testosterone
levels in the normal range by administration of a single 3-mL (750 mg)
intramuscular injection given once at initiation of therapy, at 4 weeks, and
then every 10 weeks thereafter," the company said in a statement. The drug
is expected to be available in early March.
Concerns about castor oil
Aveed is approved with a Risk Evaluation and Mitigation System (REMS) requiring
prescriber education and certification as well as restricted product
distribution. The FDA rejected the treatment last May, saying that the company
needed a better plan to manage risks associated with the long-acting drug that
contains testosterone and castor oil. The FDA had expressed concerns about the
risk of the castor oil in the formulation causing blockages in blood vessels in
the lungs and of complications linked to post-injection reactions.
In February, a consumer advocacy group urged the FDA to delay its decision on
Aveed, saying drugs treating low testosterone should carry strong warnings
about the risk of heart problems. Testosterone treatments currently include
skin patches, short-acting injections and topical
gels. AbbVie Inc's AndroGel, the market leader, generated about $1.2
billion in sales in 2012.
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