FDA Denies Auxilium Petition for Extra Hurdles for Rival’s Testosterone Product

The FDA has again found Upsher-Smith Laboratories’ testosterone gel Vogelxo therapeutically equivalent to Auxilium’s Testim — knocking down Auxilium’s citizen petition demanding higher hurdles for 505(b)(2) NDAs aimed at its therapy.

Upsher-Smith’s Vogelxo (testosterone) application sufficiently demonstrated safety, efficacy and bioequivalence to Testim (testosterone), the FDA says in its Feb. 9 response. Vogelxo was originally filed as an ANDA referencing Testim, but USL changed that application to a 505(b)(2) at the agency’s request because the therapies have different inactive ingredients, the letter says. Vogelxo was approved last June.

Auxilium’s March 26, 2013, citizen petition urged the FDA to grant Vogelxo equivalence to Testim only if it showed bioequivalence and was proven not to rub off on other people. The drugmaker also demanded that USL’s labels be substantially the same as its own and include a warning that the drug cannot be switched with other testosterone gels.

The FDA says the first three conditions have been met.

However, the agency refused Auxilium’s request for a warning against swapping Vogelxo with other testosterone therapies. While the label is required to note that testosterone therapies may have different doses, strengths or application instructions, adding the additional warning would be misleading because Vogelxo is in fact therapeutically equivalent to Testim, the FDA says.

Auxilium also asked, and was denied, that the FDA undertake additional rulemaking on testosterone therapies before assigning Vogelxo or any other testosterone therapy an equivalence rating.

Auxilium was recently purchased by Endo, which did not respond to a request for comment by press time. — Bryan Koenig