Azmiro first prefilled testosterone cypionate injection approved by the FDA now available in US

madman

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The therapy is the first and only prefilled testosterone cypionate injection approved by the FDA.

Testosterone replacement therapy Azmiro is now available in the United States for use in male patients who have conditions that are associated with a deficiency or absence of endogenous testosterone, Azurity Pharmaceuticals announced in a release.1 The therapy is the first and only prefilled testosterone cypionate injection approved by the FDA.

Azmiro comes as a 200 mg/mL single dose syringe and is intended for intramuscular use. This prefilled option provides greater accuracy and safety by reducing the potential for inadvertent needle sticks and exposure to products while drawing from a vial, as well as a reduced risk of microbial contamination. The safety and efficacy of Azmiro has not been established in men with age-related hypogonadism.

“Azurity’s purpose is to serve overlooked patients by developing innovative dose forms and formulations to serve unmet needs,” Richard Blackburn, CEO of Azurity, said in a release.1 “The commercial availability of Azmiro offers a convenient prefilled option for healthcare providers administering testosterone to patients.”

Testosterone deficiency, also known as hypogonadism, impacts between 20% to 50% of males in the US.2 The condition increases with age, with a particular rise in men aged 45 to 50 years. Low testosterone can also be caused by some conditions, including Klinefelter syndrome, mumps orchitis, and undescended testicles. Testosterone deficiency can lead to low energy, depression, poor concentration, low libido, and erectile dysfunction.

Testosterone replacement therapy has shown to improve the symptoms of hypogonadism and overall quality of life in patients with low serum testosterone.3 Research has shown that it can improve sexual function, bone density, muscle mass, body composition, mood, erythropoiesis, and cognition. Although testosterone replacement therapy does come with a potential risk for adverse events, it remains a safe and beneficial options for patients.
 

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