UPDATE: European Agency Recommends Recall Of Gilead's Vistide
December 13 2011 - 4:38PM
Dow Jones News
The European Medicines Agency, or EMA, on Tuesday recommended a
precautionary recall of one batch of Gilead Sciences Inc.'s (GILD)
Vistide antiviral drug due to potential contamination risks.
The Vistide batch in question was made at Ben Venue
Laboratories, a contract drug manufacturer that suspended
production at its Bedford, Ohio, plant in November to address
various manufacturing deficiencies.
Ben Venue's deficiencies have had a ripple effect, leading to
recalls of other drugs as well as an ongoing shortage of Johnson
& Johnson's (JNJ) cancer drug Doxil. Ben Venue, a unit of
Boehringer Ingelheim GmbH, makes sterile, injectable drugs on
behalf of multiple companies.
Gilead has started to communicate with affected customers to
implement the recall of Vistide, said spokeswoman Erin Rau. Since
February, Gilead's Vistide supplies have come from "other batches
and manufacturing routes, which are not subject to this recall,"
she said. The recall shouldn't affect overall availability of the
product.
Vistide is approved to treat cytomegalovirus infections of the
retina.
The EMA on Tuesday said an advisory body initially concluded in
November that supplies of Vistide made at Ben Venue could continue
to be used because the drug is sterilized at the end of the
manufacturing process.
However, the EMA said it has now discovered possible
contamination with particles, and the sterilization process
couldn't guarantee the absence of particles in vials of
Vistide.
The EMA said the recall won't cause a Vistide shortage because
an alternative manufacturer is now supplying the European
market.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581;
peter.loftus@dowjones.com
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