Upsher-Smith Laboratories has received an AB (therapeutic equivalent) rating from the US Food and Drug Administration (FDA) for its previously-approved Vogelxo (testosterone) gel 1 per cent unit-dose tubes and packets. FDA determined that Vogelxo is therapeutically equivalent to Testim (testosterone gel) and can be substituted with the expectation that it will produce the same clinical effects and safety profile as Testim when used in accordance with the conditions specified in the labelling.
Upsher-Smith's Vogelxo and its authorised generic testosterone gel 1 per cent are prescription medicines used to treat adult males who have low or no testosterone and with conditions associated with low or no testosterone. They provide once-daily dosing with 24-hour transdermal delivery of testosterone and are available in three convenient configurations: unit-dose tubes and packets and metered-dose pumps. Upsher-Smith's testosterone gel is the first and only generic transdermal testosterone replacement therapy (TRT) to be available in three configurations.
"We are pleased that Vogelxo tubes and packets and, by extension, its authorised generic testosterone gel 1 per cent tubes and packets, received an AB rating," says Rusty Field, chief commercial officer, Upsher-Smith. "At Upsher-Smith, we strive to bring high-quality medications to market that are more affordable and accessible to patients."