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| |  FDA Approves 1.25 Mg Cenestin (Synthetic Conjugated Estrogens) Tablets CINCINNATI, OH -- March 13, 2000 -- Duramed Pharmaceuticals announced that the United States Food and Drug Administration (FDA) has approved the company's supplemental new drug application for Cenestin(R) (synthetic conjugated estrogens, A) Tablets for the 1.25 mg dosage strength. Cenestin, which was awarded FDA approval for the 0.625 mg and 0.9 mg strengths last year is Duramed's plant-derived, synthetic conjugated estrogens product for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The addition of the 1.25 mg strength tablet to the Cenestin family now provides the physician more complete dosing flexibility in the treatment of menopausal vasomotor symptoms. Manufacturing of the 1.25 mg dosage has begun at Duramed's Cincinnati manufacturing facility and distribution will commence immediately. "This is a significant approval for Duramed," said Chairman and Chief Executive Officer E. Thomas Arington. "The 1.25 mg strength represents a $200 million market, accounting for approximately 19 percent of all conjugated estrogens prescriptions written and 23 percent of total conjugated estrogens revenues in the U.S. last year. The 1.25 mg price will be equal to the Cenestin 0.9 mg tablet, imposing no price penalty for the use of the higher dosage form. This yields an average wholesale price of 20 to 27 percent under Premarin(R)1 1.25 mg, depending upon package size." "The conjugated estrogens market was estimated to be $1.4 billion in 1998. With this approval, Cenestin now is available in dosage strengths used by more than 95 percent of the women receiving conjugated estrogens, giving them a plant-based alternative for the treatment of moderate-to-severe vasomotor symptoms. Further, as we look forward to mid-2000, we expect to complete the Cenestin family with the anticipated approval of the 0.3 mg dosage," said Arington. "Duramed's sales force continues to aggressively market Cenestin and increase education and awareness among physicians and consumers. We are working to maximize the resources and strengths gained through our marketing alliance with Solvay Pharmaceuticals. This means more expansive, more visible market coverage for Cenestin in all of the approved dosages," he noted. David A. Dodd, President and Chief Executive Officer, Solvay Pharmaceuticals, commented, "Since our joint marketing of Cenestin was initiated, prescriptions for the product from OB/GYNs have increased almost five-fold. The addition of the 1.25 mg dosage form will help make our joint marketing efforts even more successful. Cenestin is a significant product in the women's health arena and we are pleased to be working with Duramed on the marketing efforts." Duramed successfully completed clinical trials in July 1999 that established the bioequivalence of one 1.25 mg strength tablet of Cenestin to two of the approved 0.625 mg Cenestin Tablets. Arington commented, "Our clinical trials found the 1.25 mg strength dose, which is proportional to the 0.625 mg tablets, to be essentially identical to the 0.625 mg strength in rate and extent of absorption of the active ingredients into the bloodstream. We are pleased to be able to again demonstrate the precision, consistency and stability of the Cenestin formulation. Our communications with physicians will stress the confidence they can have in our formulation as they work with patients to determine the appropriate dosage level for each individual." Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. Solvay Pharmaceuticals is the second largest pharmaceutical company in the U.S. hormone replacement therapy market, having advanced from its previous standing of sixth in the industry in 1996. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group's members employ some 33,000 people in 46 countries. Its 1999 revenue worldwide was 7.9 billion EUR ($7.9 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Notes: Related Link: Solvay Pharmaceuticals, Inc.
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