FDA actions in brief

November 8, 2013

Hydrocodone bitartrate extended-release capsules (Zohydro ER, Zogenix) was approved for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. 

Hydrocodone bitartrate extended-release capsules (Zohydro ER, Zogenix) was approved for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. 

Flutemetamol F 18 injection (Vizamyl, for GE Healthcare by Medi-Physics) radioactive diagnostic drug was approved for use with positron emission tomography imaging of the brain in adults being evaluated for Alzheimer’s and dementia.

Macitentan  (Opsumit, Actelion Pharmaceuticals US) was approved for the treatment of adults with pulmonary arterial hypertension.

Diclofenac (Zorvolex, Iroko Pharmaceuticals) capsules for the treatment of mild-to-moderate acute pain in adults. Zorvolex was approved at dosage strengths that are 20% lower than currently available diclofenac products.

New indication for alvimopan (Entereg, Cubist Pharmaceuticals) was approved to include the use to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis (ie, re-connection of the bowel following removal of the resected segment.

Subcutaneous formulation of tocilizumab (Actemra, Genentech, a member of the Roche Group) was approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have used 1 or more disease modifying anti-rheumatic drug antagonists, such as methotrexate, that did not provide enough relief.

Cross-linked hyaluronic acid (Juvederm Voluma XC, Allergan) was approved to temporarily correct age-related volume loss in the cheek area in adults who are older than aged 21 years.

Turoctocog alfa (Novoeight, Novo Nordisk) was approved for the prevention and treatment of bleeding in people with hemophilia A.

Methotrexate injection (Otrexup, Antares Pharma) was approved for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full-dose non-steroidal anti-inflammatory agents (NSAIDs), or children with active polyarticular juvenile idiopathic arthritis. FDA also approved adult use of Otrexup for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. It is the first FDA-approved subcutaneous methotrexate for once-weekly self-administration with an easy-to-use, single-dose, disposable auto injector.

Riociguat (Adempas, Bayer HealthCare Pharmaceuticals) tablets were approved for the treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH and adults with pulmonary arterial hypertension.

Under a priority review to help alleviate a drug shortage, lipid injectable emulsion, USP (Clinolipid, Baxter Healthcare) was approved for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink.

Conjugated estrogens/bazedoxifene (Duavee, Pfizer) 0.45-mg/20-mg tablets were approved for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis.

Pertolizumab pegol (Cimzia, UCB) was approved for the treatment of adult patients with active psoriatic arthritis.

Updated product specifications for lucinactant (Surfaxin, Discovery Labs) Intratracheal Suspension was approved for the prevention of respiratory distress syndrome in premature infants at high risk for RDS.