Premarin reformulation approved
FDA approved a reformulation of Premarin (conjugated estrogens) 1.25 mg tablets Aug. 26. Manufacturing improvements were made and inactive ingredients changed, resulting in more robust dissolution profile, Wyeth says. Premarin 1.25 mg is first strength of the hormone therapy to use new process. FDA's Sept. 1 enforcement report lists more wholesaler recalls of Premarin due to dissolution failure (see recalls, p. 42)....
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