Today was the last day Durameds' competitors could file with the FDA to block the approval of their synthetic estrogen. (They had filed recently that Durameds' new product lacked one compound found in natural estrogen (horse urine), the FDA replied that the missing compound does not affect its performance, and that the missing compound is actually a toxin/byproduct of horse urine and is limited to the amound allowed in current generation estrogen products. I've talked to several people from Duramed and they feel confident with their new product. They could not give me any specifics, or wouldn't, but said they hope to have FDA approval by the end of Dec. if not sooner, and that there is no known reason why it will not receive final approval. Does anyone else have any comments or info about duramed or their products?
Its difficult to find behind the scenes info on the web. |
