FDA actions in brief, December 2008 (Kogenate FS, Treanda, Prezista, Seroquel XR, Apriso, Precedex, Reyataz, Vaprisol, LoSeasonique, Astepro, Apidra, Risperdal Consta, Stalevo, Akten, Taxus, Ontak)

Antihemophilic factor (recombinant) (Kogenate FS, Bayer) was approved to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged ≤16 years with severe hemophilia A and with no pre-existing joint damage.

Bendamustine for injection (Treanda, Cephalon) was approved for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Darunavir (Prezista, Tibotec) was approved for once-daily dosing as part of HIV combination therapy in treatment-naïve adult patients. The accelerated approval of darunavir for twice-daily dosing in combination with other antiretroviral agents in treatment-experienced adult patients was also converted to a full approval. Once-daily quetiapine extended-release tablets (Seroquel XR, AstraZeneca) were approved for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

Dexmedetomidine injection (Precedex, Hospira) was approved for use in nonintubated patients requiring sedation before and/or during surgical and other procedures.

Atazanavir (Reyataz, Bristol-Myers Squibb) boosted with ritonavir was approved as part of combination therapy in treatment-naïve patients with HIV-1. A formulation of conivaptan injection premixed in 5% dextrose (Vaprisol, Astellas) was approved for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.

Levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg extended-cycle oral contraceptive (LoSeasonique, Barr) was approved for the prevention of pregnancy.

A formulation of azelastine (Astepro, Meda) was approved for the treatment of seasonal allergic rhinitis.

Insulin glulisine (rDNA origin) injection (Apidra, Sanofi-Aventis) was approved to improve glycemic control in children aged ≥4 years with diabetes mellitus.

A new injection site was approved for risperidone long-acting injection (Risperdal Consta, Alkermes) for the treatment of schizophrenia. The agent can now be injected in the deltoid muscle. New dosages of carbidopa/levodopa/entacapone (Stalevo, Novartis) were approved for the treatment of Parkinson disease in patients who experience end-of-dose "wearing off." These new dosages are carbidopa 18.75 mg/levodopa 75 mg/entacapone 200 mg and carbidopa 31.25 mg/levodopa 125 mg/entacapone 200 mg.

An ophthalmic gel 3.5% formulation of lidocaine (Akten, Akorn) was approved for use as a topical, ocular anesthetic agent during ocular procedures.

A drug-eluting stent (Taxus Liberte Paclitaxel-Eluting Coronary Stent System, Boston Scientific) was approved for the treatment of coronary artery disease.

The accelerated approval of denileukin diftitox (Ontak, Eisai) for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor was converted to a full approval.