Teva Pharmaceutical Industries Ltd, a leading global pharmaceutical company, announced the exclusive launch of the generic equivalent to Avodart (dutasteride) capsules, 0.5 mg, in the United States. Dutasteride is a 5 alpha-reductase enzyme inhibitor and works by lowering production of a hormone called dihydrotestosterone (DHT). Dutasteride capsules are used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Teva was first to file and expects to be exclusive for several weeks.
Avodart capsules, marketed by GlaxoSmithKline, had annual sales of approximately $467 million in the United States, according to IMS data as of July 2015.
Dutasteride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery. Dutasteride capsules in combination with the alpha adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Dutasteride capsules are not approved for the prevention of prostate cancer.
Dutasteride capsules are for use for men only. Dutasteride capsules are contraindicated for use in: pregnancy and women of childbearing potential; pediatric patients; and patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride or other 5 alpha-reductase inhibitors.
Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50 per cent. However, any confirmed increase in PSA while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. Dutasteride may increase the risk of high-grade prostate cancer. Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. Women who are pregnant or could become pregnant should not handle dutasteride capsules due to potential risk to a male fetus. Patients should not donate blood until 6 months after their last dose of dutasteride.
The most common adverse reactions, reported in = 1 per cent of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders.