Register for Cenestin 0.45-mg tablets approved by FDA
MenopauseMarch 4, 2004
2004 MAR 4 - (NewsRx.com & NewsRx.net) -- Barr Pharmaceuticals, Inc., (BRL) announced that its wholly owned subsidiary, Duramed Pharmaceuticals, Inc., received approval from the U.S. Food and Drug Administration for its supplemental New Drug Application (sNDA) for Cenestin (Synthetic Conjugated Estrogens, A) tablets 0.45 mg.
This additional dosage strength, which brings to five the number of dosage strengths available in the Cenestin product line, is the lowest Cenestin dose approved for the treatment of moderate to severe vasomotor symptoms associated with menopause. Cenestin competes in the hormone therapy (HT) market and provides women who choose to take hormone products with a plant-derived option.
The company expects to begin initial shipments of its 0.45 mg tablet dosage strength to the trade in April 2004. Barr currently markets Cenestin in four dosage strengths; 0.3 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets. Barr's Cenestin 0.3 mg tablet dosage strength is indicated only for the treatment of vulvar and vaginal atrophy.
"The approval of the Cenestin 0.45 mg tablet dosage strength continues our commitment to offer American women a full line of plant-derived synthetic conjugated estrogen products. It also represents a significant expansion of our current product line to include the lowest strength of Cenestin approved for vasomotor symptoms," said Bruce L. Downey, Barr's chairman and CEO. "We currently have a vaginal cream Cenestin product in phase III clinical trials and believe that our commitment to expand the Cenestin product line provides physicians and patients with additional therapeutic choices and flexibility as they make important decisions regarding hormone therapy."
The company has a 226-person women's healthcare sales force that currently promotes Cenestin directly to physicians, under the Duramed Pharmaceuticals, Inc., name. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals, Inc., resulting from the 2001 merger of Barr and Duramed.
Estrogen use that is unopposed by progestin is associated with an increased risk of endometrial cancer in postmenopausal women with intact uteri. Estrogens should not be used in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, thromboembolic disorders, active or recent arterial thromboembolic disease, or pregnancy. Estrogens should not be used for the prevention of cardiovascular disease.
The Women's Health Initiative study reported increased risks of myocardial infraction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis. Due to these risks, estrogen with or without progestins should be prescribed at the lowest effective dose for the shortest duration, consistent with treatment goals and risks for the individual woman; periodic clinical reevaluation of such therapy is also advised. This article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
