New drugs may be more effective than ever, but they are also hard to manufacture, as these companies can attest
NORTHFIELD LABORATORIES The FDA refused to accept a new drug
application for the product in November,
POLYHEME in part because it wanted more info on the
(BLOOD SUBSTITUTE) manufacturing process
ENZON/SCHERING-PLOUGH The drug was introduced to the U.S. in
PEG-INTRON October, and by January demand overwhelmed
(HEPATITIS-C) supply, forcing Schering-Plough to create
a waiting list
IDEC PHARMACEUTICALS The FDA deemed the drug approvable in January
ZEVALIN but delayed the final O.K. for six weeks
(NON-HODGKIN'S LYMPHOMA) because of manufacturing issues
AVIRON/AMERICAN HOME In September, the FDA requested more clinical
FLUMIST and manufacturing data on the nasal spray
INFLUENZA vaccine, delaying approval by at least a year
XOMA/GENENTECH In October, the drug's approval application
XANELIN was delayed after manufacturing modifications
PSORIASIS were made during late stage clinical trials
MARCH 3, 2002
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