The FDA approved Imclone’sErbitux (cetuximab) in combination with radiation therapy for the treatment of a certain type of locally or regionally advanced head and neck cancer. Erbitux was also approved for use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and who have failed platinum-based chemotherapy.
Pfizer’sEraxis (anidulafungin) has been approved by the FDA to treat candidemia, a potentially life-threatening bloodstream infection. Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of approximately 40%. In the US, candidemia affects approximately one in 5,000 people, resulting in an estimated 60,000 cases each year.
Warner Chilcott announced that the FDA has approved its 24-day oral contraceptive, Loestrin 24 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), for the prevention of pregnancy. Loestrin 24 is the first birth-control pill approved in the US that provides 24 days of active hormonal therapy and four days of iron-containing placebo pills.
Sanofi-Aventis announced it has received from the FDA’s Division of Metabolism and Endocrinology Products an approvable letter for rimonabant for weight management, and from the Division of Anesthesia, Analgesia and Rheumathology Products, a non-approvable letter, for smoking cessation.
Santarus, said the FDA has approved its NDA for Zegerid (omeprazole/sodium bicarbonate), an immediate-release proton pump inhibitor (PPI).