>>>>NEWS! Nasdaq: DRMD - FDA Approval
Company Press Release
SOURCE: Duramed Pharmaceuticals, Inc.
FDA Authorizes Duramed Pharmaceuticals, Inc. to Market Cimetidine HCL Oral Solution
CINCINNATI, June 19 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD - news) today announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Cimetidine HCL Oral Solution, which is used to treat ulcers. The FDA granted Duramed's Cimetidine HCL Oral Solution a
therapeutic equivalency rating of AA, designating the product as completely interchangeable with Tagamet Liquid, for all new and refill prescriptions.
E. Thomas Arington, Chairman and Chief Executive Officer of Duramed said, ''We are pleased to receive this approval as further evidence of our product development capabilities and look forward to additional approvals in future periods.''
Arington noted that several other firms already have approval to market generic equivalents for this product. He added, however, that this approval helps Duramed round out its product line to better serve its customers' overall needs. Duramed expects to begin manufacturing and marketing Cimetidine HCL Oral Solution late in the third quarter of 1998.
About the Company
Duramed Pharmaceuticals, Inc. currently develops, manufactures and markets prescription drug products. The Company's product development program is focused on hormonal therapies and controlled release technology. On March 30, 1998, the Company submitted its first New Drug Application (NDA), for its synthetic conjugated estrogens product. When approved by the FDA, the product will be marketed under the brand name Cenestin(TM). The worldwide estrogen replacement market is approaching $2 billion and growing at a rate of 15 percent per year.
The Company's common stock is traded on Nasdaq under the symbol DRMD. Additional information on the Company can be found on the World Wide Web at duramed.com.
The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes,
the achievement of forward- looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed's SEC filings, including its annual report on Form 1O-K.
SOURCE: Duramed Pharmaceuticals, Inc. |
