Berlex, Inc., a U.S. affiliate of Schering AG, Germany, has announced the FDA’s approval of a monophasic oral contraceptive (Yaz). This is the first tablet to combine 20 mcg of ethinyl estradiol generic with 3 mg of the progestin drospirenone. This 24-day regimen causes less hormonal fluctuation than traditional oral contraceptives providing a 21-day course. In a [...]]]...

Genentech, Inc., and Biogen Idec have announced the FDA’s approval of the therapeutic antibody rituximab (Rituxan) in combination with generic methotrexate (MTX) for adults with moderately to severely active rheumatoid arthritis (RA) who have not responded adequately to one or more tumor necrosis factor antagonist therapies. This is the first RA therapy that targets immune [...]]]...

Two prescription creams used to treat eczema will now carry strong warnings about the possible risk of skin cancer, lymphoma, and other cancers associated with their use. The packaging for pimecrolimus (Elidel, Novartis AG) and medication tacrolimus (Protopic generic, Astellas Pharma) will contain “black-box” warnings—the strongest type used in the U.S.—10 months after the agency first [...]]]...

The FDA has approved ibandronate sodium (Generic Boniva Injection, Roche/Glaxo-SmithKline), the first quarterly IV bis-phosphonate indicated for the treatment of postmenopausal osteoporosis. IV ibandronate is administered by a health care professional once every three months. The process takes 15 to 30 seconds. This formulation offers an alternative for patients who have difficulty with oral bisphosphonate dosing [...]]]...

An estradiol/levonorgestrel generic trans­dermal system (Climara Pro, Schering) is now available for the prevention of postmenopausal osteoporosis in the U.S. This patch was approved in 2003 to treat moderate-to-severe vasomotor symptoms such as hot flashes and night sweats associated with menopause. The transdermal patch allows for week-long continuous delivery of the hormone estradiol drug (0.045 mg/day), combined [...]]]...