Foreign API Manufacturers Help Ease Methotrexate Shortage
Generic drug manufacturers needed to find additional manufacturers of active pharmaceutical ingredients to fill a gap in production of the vital cancer drug methotrexate.
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In the six months since an executive order encouraged firms to provide early notification of potential shortages, FDA has prevented 128 of them, FDA Commissioner Hamburg reports. She attributes the success to manufacturers’ early notification of potential disruptions in drug supply.
Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts.
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.