FDA Approves Selective Estrogen Receptor Modulator

The FDA has approved Glenmark Pharmaceuticals Inc’s abbreviated new drug application for raloxifene hydrochloride tablets USP, 60 mg, which is the therapeutic equivalent to Eli Lilly and Company’s Evista.

Evista, a selective estrogen receptor modulator, is typically given to women after menopause. It can treat and prevent osteoporosis, as well as reduce the risk of invasive breast cancer. Evista is not recommended for premenopausal women.

Pharmacists can inform individuals who take raloxifene hydrochloride that they have an increased risk of venous thromboembolism and death from stroke. Women with a past history of stroke or venous thromboembolism should avoid taking the drug.

Patients who have or have had blood clots in the legs, lungs, or eyes should also not take raloxifene hydrochloride. In addition, women who are pregnant or who could become pregnant, as well as women who are nursing, should not take the product.

The most common adverse effects associated with the treatment are hot flashes; leg cramps; swelling of the feet, ankles, and legs; and flu-like symptoms. Some individuals may also experience joint pain and sweating.

Glenmark currently has 60 abbreviated new drug applications awaiting approval from the FDA.