FDA Actions in Brief February 2012 (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)

February 1, 2012

Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)

Glucarpidase (Voraxaze, BTG International) was approved for the treatment of patients with toxic levels of blood due to kidney failure.

A product label update for natalizumab (Tysabri, Biogen Idec, Elan) was approved that will help enable individual benefit-risk assessment for patients with multiple sclerosis. The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy.

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Prevnar 13, Pfizer) was approved as a single dose for use in adults aged 50 years and older as a new indication. Prevnar is indicated for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine.

Fentanyl sublingual spray (Subsys, INSYS Therapeutics), a sublingually-administered formulation of fentanyl in a novel delivery device, was approved for the treatment of adults who experience episodes of breakthrough cancer pain.

Bortezomib (Velcade, Takeda) was approved to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least 1 prior therapy.

A label expansion was approved for self-administration of C1 esterase inhibitor (human) (Berinert, CSL Behring), a pasteurized, nanofiltered therapy for the treatment of acute attacks of hereditary angioedema (HAE). With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks.

Azilsartan medoxomil and chlorthalidone (Edarbyclor, Takeda) was approved for the treatment of hypertension to lower blood pressure in adults. Edarbyclor is the only fixed-dose therapy in the United States to combine an angiotensin II receptor blocker with the diuretic chlorthalidone in a once-daily, single tablet.

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