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.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.