FDAnews Drug Daily Bulletin

FDA RELEASES GUIDANCE ON NONCONTRACEPTIVE ESTROGEN DRUG PRODUCTS

Nov. 23, 2005
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The FDA has released a final guidance to provide manufacturers with recommendations on prescribing information and patient labeling for noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms.

The guidance includes specific prescribing information for healthcare providers, as well as the recommended text for the patient information leaflet for noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms.

The final guidance updates draft guidances issued by the agency in October 1998, Feberuary 2003 and February 2004.

To view the guidance, go to http://www.fda.gov/cder/guidance/6932dft.htm.