FDA actions in brief

FDA extended the Prescription Drug User Fee Act action date to January 7, 2006, for lenalidomide (Revlimid, Celgene). The drug is intended to treat patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.

Zileuton (Zyflo, Critical Therapeutics) was approved for the prevention and chronic treatment of asthma in patients aged 12 years and older.

Exemestane (Aromasin, Pfizer) was approved for adjuvant treatment of postmenopausal women with estrogen-receptor-positive early breast cancer following 2 to 3 years of tamoxifen for a completion of 5 consecutive years of adjuvant hormonal therapy.

Insulin detemir (Levemir, Novo Nordisk) was approved by FDA for pediatric use. The agent was first approved in June 2005 for use in adults. Insulin detemir will be launched for adults and children within the next 8 months, according to the company.

FDA approved tamoxifen oral solution (Soltamox, Savient Pharmaceuticals) for treating adjuvant and metastatic breast cancer and for reducing the risk of breast cancer in women with a high risk of the disease, as well as in those with ductal carcinoma in situ. The formulation will be the first oral liquid tamoxifen solution available in the United States.

Deferasirox (Exjade, Novartis), a once-daily oral iron chelator, was approved by FDA for the treatment of chronic iron overload resulting from blood transfusions in adults and children aged 2 years or older. The tablets are dispersed in a glass of juice or water, whereas the current standard of care, deferoxamine, often requires a subcutaneous infusion lasting 8 to 12 hours per night for 5 to 7 nights a week as long as the patient has excess iron.