SCE-ATreatment for Postmenopausal Symptoms
Update: Synthetic Conjugated Estrogens-A Vaginal Cream Now FDA Approved - November 28, 2008
Barr's Receives Not Approvable Letter for Bijuva Vaginal Cream
WOODCLIFF LAKE, N.J., April 26, 2005 -- Barr Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has issued a Not Approvable letter for Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Bijuva (Synthetic Conjugated Estrogens, A) Cream. Duramed is a wholly-owned subsidiary of Barr. The Company is working with FDA to resolve the outstanding issues on the Bijuva application as soon as is practical. Once approved, the Company intends to market Bijuva for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
"We have worked closely with the Agency as the review process for our Bijuva vaginal cream product has advanced and, although we are disappointed in the Agency's decision, we are confident that the matters raised in the Agency's Not Approvable letter can be resolved," said Dr. Carole S. Ben- Maimon, President and COO of Duramed Research.
The Company is committed to the estrogen therapy marketplace and currently promotes Cenestin 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets directly to physicians with its Duramed 226-person Women's Healthcare Sales Force. The Company's pipeline of future estrogen therapy products also includes Enjuvia, which is expected to launch following the anticipated approval of a 0.9 mg tablet product strength in fiscal 2006. The Company currently has approval for its Enjuvia line 0.3 mg, 0.45 mg, 0.625 mg and 1.25 mg tablet strengths 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.
Important Information About Estrogens
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 (WHI) 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.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Posted: April 2005
- FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream - December 1, 2008