News
New Drug Actonel (risedronate sodium tablets) and Activella for the new Indication of the Prevention of Osteoporosis
St. Louis - The FDA has cleared for marketing the new drug Actonel for the treat
St. Louis - The FDA has cleared for marketing the new drug Actonel for the treatment of osteoporosis and approved a new indication for Pharmacia & Upjohn's Activella.
Actonel (risedronate sodium tablets) is indicated in the treatment and prevention of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis. Procter & Gamble, the inventor of Actonel, and Aventis Pharmaceuticals will market the drug collaboratively.
Actonel 5 mg is the first osteoporosis therapy to consistently demonstrate a reduction in vertebral fractures in just one year of treatment. Additionally, Actonel is the only therapy to show this one-year vertebral fracture benefit in patients with glucocorticoid-induced osteoporosis as well.
Actonel should not be used in patients with low blood calcium or in patients with severe kidney disease.
The FDA also approved Pharmacia & Upjohn's Activella for the new indication of the prevention of osteoporosis. Activella is a continuous-combined once daily tablet combining estrogen (1 mg estradiol) and progestin (0.5 mg norethindrone acetate). It was previously approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause and for vulvar and vaginal atrophy associated with menopause.
Common side effects may include breast tenderness/pain, upper respiratory complaints, headache and postmenopausal bleeding.