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

To: TED AROESTY who wrote (897)	2/9/1999 12:30:00 PM
From: rascalbythesea	Respond to of 1837

they would not have been able to file for an NDA on March 31, 1998 had they not completed phase III. btb

To: TED AROESTY who wrote (897)	2/13/1999 11:19:00 AM
From: harkenman	Read Replies (2) \| Respond to of 1837

Phase III is in process for Cenestin since IND was approved as well as filing of the NDA. The IND submited you refer to in the DuraMed web site is for MPA in combination with Cenestin. They filed an IND for this. Once IND is results are in, they can file an NDA where phase III clinicals are done. The MPA Cenestin combo will compete head to head with PreM-Pro - Prem Phase product from American Home (Ayerst Wyeth) which combines Conjugated Estrogens with MPA.