FDA Actions in Brief July 2010 (Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna)

Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna

Memantine hydrochloride (Namenda XR, Forest and Mertz) was approved for the treatment of moderate-to-severe dementia of the Alzheimer's type.

Fixed-dose combination of mometasone furoate and formoterol fumarate dihydrate (Dulera, Merck) inhalation aerosol was approved for asthma treatment for patients 12 years of age and older.

A new indication for ranibizumab injection (Lucentis, Genentech) was approved for the treatment of macular edema following retinal vein occulsion.

Lacosamide (Vimpat, UCB) C-V 10 mg/mL oral solution formulation was approved for add-on treatment of partial-onset seizures in patients aged 17 years and older with epilepsy. This new formulation allows for consistent treatment in patients who may have trouble swallowing pills, such as older adults or individuals in long-term care settings.

Cabazitaxel (Jevtana, Sanofi-aventis) injection in combination with prednisone was approved for the treatment of patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing treatment regimen.

The first diagnostic assay to detect both antigen and antibodies to HIV was approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection (Architecht HIV Ag/Ab Combo assay, Abbott) in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as aged 2 years.

A new indication for nilotinib (Tasigna, Novartis) was approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.