Pfizer Inc. is preparing to seek U.S. regulatory approval to sell a new menopause drug that could pose an alternative to the company’s older hormone-replacement therapies, which have been tied to safety risks. However, repeated delays in developing the new drug, Aprela, have raised questions about its potential. Some analysts and doctors question whether regulators will approve it, and Aprela’s market potential could be limited by continued safety concerns about hormone-based drugs. The New York-based drug maker expects to submit Aprela for U.S. Food and Drug Administration approval sometime this year, Olivier Brandicourt, president and general manager of Pfizer’s primary care unit, said in an interview earlier this month.
