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Approvable letter for Berlex' Angeliq hormone therapy tablets requests additional manufacturing information for the chemistry, manufacturing and control dossier. The company anticipates a 2005 approval for the lowest dose submitted, 0.5 mg drospirenone and 1 mg estradiol. The drug is in Phase III trials for an antihypertensive indication for the 1 mg and 3 mg drospirenone doses...
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