Warner Chilcott's Low-Dose FemHRT Clears FDA
This article was originally published in The Pink Sheet Daily
Company says low-dose FemHRT is "consistent" with hormone replacement therapy guidelines. The drug's second quarter launch could coincide with the introduction of Warner Chilcott's other recently approved hormone replacement therapy, Femtrace.
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Company sees a “small but consistent” increase in prescription volume and share for the hormone therapy, VP O’Connor says. Growth could indicate “swinging back of the pendulum” following two-year downturn resulting from the Women’s Health Initiative results.
Warner Chilcott's hormone therapy clears FDA for the treatment of the vasomotor symptoms of menopause. Approval is not granted for a vulvar-vaginal atrophy indication, however. The company will use part of its 400-person U.S. sales force to market the product.
Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.