FDA Actions in Brief September/October 2010 (Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz)

Fingolimod (Gilenya, Novartis) was the first approved oral treatment indicated for relapsing forms of multiple sclerosis.

Denosumab (Prolia, Amgen) was approved for the treatment of postmenopausal women with osteporosis at high risk for fracture.

Pegloticase (Krystexxa, Savient) was approved for the treatment of gout in adult patients refractory to conventional therapy.

Pralidoxime chloride (Protopam Chloride, Baxter Healthcare) was approved for the treatment of pesticide poisoning in children.

Dexamethasone intravitreal implant (Ozurdex, Allergan) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

Buprenorphine and naloxone (Suboxone Film, Reckitt Benckiser Pharmaceuticals) sublingual film (C-III) was approved for the maintenance treatment of opioid dependence.

Asenapine (Saphris, Merck) sublingual tablets was approved for expanded indications and is now indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Aliskiren and amlodipine (Tekamlo, Novartis) single tablet was approved for the treatment of high blood pressure.

Estrogen/progestin combined oral contraceptive tablets that also contain a folate (levomefolate calcium 0.451 mg) (Beyaz, Bayer HealthCare) was approved for the prevention of pregnancy; treatment of symptoms of premenstrual dysphoric disorder in women who choose to use an oral contraceptive for contraception; and treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.