Teva to stop manufacturing propofol sedative
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This article is from May 2010, so not breaking news, but I did not find it in other topics.
Thu May 27, 2010 8:54pm EDT
* Will continue to support propofol already on the market
* FDA had flagged manufacturing lapses at California plant
LOS ANGELES May 27 (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.TA) (TEVA.O) said on Thursday that it has decided to discontinue manufacturing propofol.
The drug is used to sedate patients before medical procedures.
Teva said in an emailed statement that it will continue to support product that is already on the market.
The FDA warned Teva, in a December 2009 letter released last month, that a 2009 inspection showed problems with the manufacture of propofol at a Teva plant in Irvine, California.
The company had failed, for example, to test each lot of raw materials used to make propofol for certain toxins, the FDA said.
Israel-based Teva earlier this month was ordered by a Las Vegas court to pay $356 million in punitive damages to a Nevada man who contracted hepatitis C two years ago after the anesthetic was reused for colonoscopy or endoscopy procedures.
Teva made the drug and Baxter International Inc (BAX.N) distributed it. Baxter was ordered to pay $144 million.
Teva said it plans to appeal, believes the evidence shows it acted responsibly and the clinic did not follow instructions to change needles after each patient. (Reporting by Deena Beasley; editing by Carol Bishopric)
This article is from May 2010, so not breaking news, but I did not find it in other topics.
Thu May 27, 2010 8:54pm EDT
* Will continue to support propofol already on the market
* FDA had flagged manufacturing lapses at California plant
LOS ANGELES May 27 (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.TA) (TEVA.O) said on Thursday that it has decided to discontinue manufacturing propofol.
The drug is used to sedate patients before medical procedures.
Teva said in an emailed statement that it will continue to support product that is already on the market.
The FDA warned Teva, in a December 2009 letter released last month, that a 2009 inspection showed problems with the manufacture of propofol at a Teva plant in Irvine, California.
The company had failed, for example, to test each lot of raw materials used to make propofol for certain toxins, the FDA said.
Israel-based Teva earlier this month was ordered by a Las Vegas court to pay $356 million in punitive damages to a Nevada man who contracted hepatitis C two years ago after the anesthetic was reused for colonoscopy or endoscopy procedures.
Teva made the drug and Baxter International Inc (BAX.N) distributed it. Baxter was ordered to pay $144 million.
Teva said it plans to appeal, believes the evidence shows it acted responsibly and the clinic did not follow instructions to change needles after each patient. (Reporting by Deena Beasley; editing by Carol Bishopric)