Can Watson Give Birth To A Pregnancy Franchise As It Helps Lay Lipitor To Rest?
Watson is progressing on a multi-year effort to diversify beyond its core U.S. generics business into branded drugs and international markets.
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Some members of FDA’s Reproductive Health Drugs Advisory Committee were not impressed that progesterone is already being used off-label to prevent preterm birth in women with a short cervix.
The agency rejects the sponsor’s statistical analysis and says there is no statistically significant evidence of efficacy in the U.S. population, and the product seems likely to face a request for another trial from the advisory panel.
The deal is a key part of both companies’ plans for aggressive international expansion because they will be able to spread fixed costs and offer robust portfolios to vastly different geographically diverse customers.