Off-Label Progesterone Use For Preventing Preterm Birth Debated At FDA Panel
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.
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The extent of additional clinical work required pursuant to an FDA “complete response” letter will have to be balanced against the remaining patent life on the product, for which Watson was seeking an indication to prevent preterm birth in women with a short cervix.
Watson is progressing on a multi-year effort to diversify beyond its core U.S. generics business into branded drugs and international markets.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.