Sanofi-aventis is alerting pharmacists to an error in the patient information leaflet (PIL) for Tarivid (ofloxacin) 200mg and 400mg tablets distributed since 2 January 2009.
The PIL incorrectly states that the 200mg tablets are marked with the letters “MXL” and that the 400mg tablets are marked with the letters “MXI”. The PIL should state that the 200mg tablets are marked with “MXI” and that the 400mg tablets are marked with “MXL”. The tablets are correctly marked.
Hope we don`t have a problem in India.
Source:pjonline.com
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YET ANOTHER BURNING PHARMA NEWS FLASH:
BOSTON/NEW YORK (Reuters) - Eli Lilly and Co (LLY.N) said on Thursday it will pay about $1.42 billion to settle criminal and civil investigations into the marketing of its antipsychotic drug Zyprexa and has agreed to plead guilty to a federal misdemeanor.
The drug maker has agreed to pay $615 million to settle the criminal probe and about $800 million to settle the civil investigations brought by State Medicaid units.
Lilly said the misdemeanor plea was for advertising Zyprexa for ailments for which it was not approved between September 1999 and March 2001 in a practice called off-label promotion.
"Specifically, the plea states that Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer's dementia, although Zyprexa is not approved for such uses," the company said in a statement.
Lilly anticipated the settlement booking $1.48 billion in charges related to the probes in the third quarter of 2008.
Zyprexa is one of Lilly's biggest selling drugs, with 2007 sales of $4.8 billion. Many physicians consider it to be the most effective in a class of drugs known as atypical antipsychotics used to treat schizophrenia, but it is also seen as one of the worst offenders in causing weight gain, which can be a precursor to diabetes.
"Eli Lilly had an army of 2,000 sales representatives engaged in nothing but off-label marketing," Laurie Magid, the Acting U.S. Attorney in Philadelphia said in an interview on Thursday.
One Lilly sales force targeted nursing homes and assisted living facilities, even though schizophrenia rarely occurs in the elderly and studies of Zyprexa called into question its effectiveness in treating psychosis from Alzheimer's disease, Magid said.
In their visits to homes for the elderly, Lilly sales reps touted weight gain from Zyprexa as a health-promoting benefit, instead of a worrisome side effect that could lead to diabetes, Magid said.
And another Lilly sales force courted primary care doctors with marketing materials, including profiles of fictitious patients called "Martha" and "Rose Jackson" who had behavior difficulties, Magid said.
Zyprexa is set to lose patent protection in 2011. Earlier this month, U.S. regulators delayed a final decision on whether to approve a long-acting form of the drug.
As part of the settlement, Lilly has entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.
Under the agreement, Lilly's drugs can be excluded from federal health programs if the company fails to comply with good-conduct assurances during the next five years.
Eli Lilly's shares were up 10 cents to $37.57 on the New York Stock Exchange in mid-afternoon trade.
SOURCE: http://www.reuters.com/article/businessNews/idUSTRE50E2Z020090115?feedType=RSS&feedName=businessNews
Pfizer management may terminate 2,400 sales reps — Bloomberg reports that the Biggest Pharma is considering the elimination of one third of its sales force. The company neither confirmed nor denied the rumor.
[Source: WSJ Health Blog]
BMS Wins Ruling That Could Crimp India’s Thriving Generics Business:
Bristol-Myers Squibbb just won a ruling in an Indian court that could put generic makers there on the defensive. For years, the Indian drug business has grown primarily from making generics. Companies like Dr. Reddy’s, Ranbaxy, Cilpa and Hetero Drugs have chosen to copy compounds marketed in the West rather than do their own R&D.
But in a case that pits BMS against Hetero, a court has ruled that Indian drug regulators should not grant marketing approvals to drugs that may be in violation of patents. According to LiveMint, the ruling states:
It is expected that the DCGI [Drug Controller General of India], while performing statutory functions, will not allow any party to infringe any laws and if the drug for which approval has been sought by the defendants is in breach of the patent of the plaintiffs, the approval ought not be granted to the defendants.
The case involves BMS’s cancer drug, dasatinib. BMS has been selling the drug in India under patent protection since 2006 under the name Sprycel. The ruling is in place until March, when the court gives the issue another hearing.
Linking product approvals to patent status is a controversial issue. On the one hand, it seems unfair that companies who go to the expense of developing and patenting their drugs should find governments approving copycat products.
On the other hand, bodies like the DCGI and the FDA are ill-equipped to do the necessary legal research on patent statuses prior to making approvals. Some say they should stick to what they are good at — which is the science, not the law — and leave the litigation to others.
LiveMint says:
This so-called patent linkage necessarily means that DCGI, who is responsible for approving drugs in India after ensuring their safety and quality, will also have to look at the patent status of the drug before granting permission for marketing.
This, experts said, could potentially halt the approval process for generic drugs in cases where the original has a patent in India. The denial of approval could also potentially last through the entire life of the patent, which could be at least a decade in some cases.
Source:
By Jim Edwards | January 16th, 2009 @ 3:16 am
Pharma Roundup: Pfizer and the Rat:
Pfizer’s gruesome new anti-counterfeit campaign — In the U.K., Pfizer has rolled out a new TV ad that warns consumers against the dangers of counterfeit drugs. The nauseating image of a man pulling a rat from his mouth intends to educate consumers about the dangerous substances (like rat poison) which lace counterfeits, but counterfeits are more of a problem in the supply chain than with end consumers. The ad’s big message is, “Don’t buy from shady websites.” See the clip here, if you have a strong stomach.
http://in.youtube.com/watch?v=t5NPMm4svdo
[Source: Drug Channels]
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