To All:
CINCINNATI, Dec. 30 /PRNewswire/ -- The U.S. Food and Drug Administration(FDA) has authorized Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD) to market Estradiol Tablets, a women's hormone replacement therapy, in the 0.5 mg, 1 mg,and 2 mg strengths. The FDA granted Duramed's Estradiol Tablets a therapeutic equivalency rating of AB, designating Duramed's Estradiol Tablets as completely interchangeable with Estrace Tablets, for all new and refill
prescriptions. In addition, the FDA granted Duramed the rights to market a 1.5 mg Estradiol Tablet, a strength which is presently unavailable from any other source. Annual manufacturers' revenue for the product in 1996 was
approximately $100 million.
Mr. E. Thomas Arington, Chairman and CEO of Duramed said, "FDA approval of this product is significant because Estradiol is the first product in our family of female hormonal products to be approved. The product will be manufactured in Duramed's state-of-the-art hormonal products facility in Cincinnati and shipment is scheduled to commence in January 1998."
Mr. Arington further stated, "As we move into 1998, we look forward to new product filings as well as FDA approvals throughout the year as the depth of our product development program becomes evident."
Regarding the company's synthetic conjugated estrogens product,
Mr. Arington commented, "Consistent with our earlier updates, Duramed is finalizing the clinical work and anticipates filing the NDA for this product during the first quarter of 1998."
Duramed Pharmaceuticals, Inc. manufactures and markets a line of
prescription generic drug products in tablet, capsule, and liquid forms.
* Estrace(R) is a registered trademark of Bristol Myers Squibb.
SOURCE Duramed Pharmaceuticals, Inc.
CONTACT: Investor Relations of Duramed Pharmaceuticals,
513-731-9900; or Media, Ellen Knight or Julie Harrison of Dan
Pinger Public Relations, 513-564-0700 |
