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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?

To: Doug Bean who wrote (847)	12/15/1998 9:43:00 PM
From: harkenman	Read Replies (1) \| Respond to of 1837

Duramed Pharma Files IND Application For Combo Estrogen Pdt Dow Jones Newswires CINCINNATI -- Duramed Pharmaceuticals Inc. (DRMD) filed an Investigational New Drug, or IND, application with the Food and Drug Administration to study the effects of medroxyprogesterone acetate, or MPA, administered cyclically in combination with Cenestin. In a press release Tuesday, Duramed also said it passed an inspection of manufacturing facilities for its synthetic conjugated estrogens tablets. The inspection was one step in the FDA's review of the the company's Cenestin product application. Duramed said the IND study will evaluate the combined drug product for the treatment of vasomotor symptoms in postmenopausal women with an intact uterus. The New Drug Application, or NDA, for Cenestin is currently under review by the FDA. Duramed expects to initiate Phase III clinical trials of the combined drugs in early 1999 and file the NDA upon successful completion of those trials. Duramed is a pharmaceutical company.