Teva Pharmaceutical Industries Ltd. today announced the launch of generic Axiron (testosterone) topical solution CIII, 30 mg/1.5 mL, in the US. Testosterone topical solution CIII is a prescription medicine used to treat adult males who have low or no testosterone due to certain medical conditions. Due to lack of controlled studies in women and potential virilizing effects, testosterone topical solution is not indicated for use in women.
Axiron had annual sales of approximately $247 million in the US, according to IMS data. The solution is supplied in a metered-dose pump with an underarm applicator.
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Teva president and CEO Global Generic Medicines North America Andy Boyer said, “We are pleased with the result in the district court, which has helped Teva add yet another product to our industry-leading generic portfolio, providing savings to our customers and to patients. Teva continues to lead the industry in bringing new generic products to the US market.”
With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US. Currently, one in six generic prescriptions dispensed in the U.S. is filled with a Teva product.