FDA Actions in Brief February 2011 (Fortesta, Natroba, Abstral, Acetadote, Viibryd, Intelence)

Testosterone Gel (Fortesta, Endo Pharmaceuticals) for topical use was approved as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism or hypogonadotrophic hypogonadism.

Spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% was approved for the treatment of head lice infestation in patients aged 4 years and older.

Fentanyl (Abstral, ProStrakan) transmucosal tablets were approved to manage breakthrough pain for adults aged ≥18 years with cancer, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication.

Vilazodone HCl tablets (Viibryd, Clinical Data) was approved for the treatment of major depressive disorder in adults.

A label update for etravirine (Intelence, Tibotec), a non-nucleoside reverse transcriptase inhibitor (NNRTI), was approved to include a 200-mg formulation. Intelence is indicated for the treatment of HIV in treatment-experienced adults with resistance to an NNRTI and other antiretroviral agents. The recommended oral dose of Intelence is 200 mg (one 200-mg tablet or two 100-mg tablets) taken twice daily following a meal. The new dosage strength will reduce the number of pills that some patients with HIV need to take daily. The 100-mg tablet will remain available.