Merck said today that the FDA has approved oral Zolinza (vorinostat) for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma, a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease on or following two systemic therapies. CTCL is a cancer of the T-cells, a type of white blood cell, which affects the skin.
The FDA has approved GlaxoSmithKline’s FluLaval (influenza virus vaccine) for immunization of adults 18 years and older against influenza disease, commonly known as the flu.
The FDA approved Berlex’s Yaz (drospirenone/ethinyl estradiol) for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. YAZ received initial FDA approval for the prevention of pregnancy in March 2006.
Sepracor said the FDA has approved its new drug application for Brovana (arformoterol tartrate) as a long-term, maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Genentech and Biogen Idec received FDA approval for two additional uses for Rituxan (rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
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