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Galen Submits New Drug Application to FDA for Intravaginal Ring.(Galen Holdings PLC completes submission for Estrace VR intravaginal ring estrogen replacement therapy)
2002 JAN 17 - (NewsRx.com & NewsRx.net) -- Galen Holdings plc (GALN, GAL.L), has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration for its intravaginal ring estrogen replacement therapy, Estrace VR.
The product, for hormone replacement therapy, was approved for use in the United Kingdom in 2001 and is marketed under the brand name Menoring. Submission to the European regulatory authorities via the Mutual Recognition ...
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