"In answering FDA's request of last week to voluntarily remove Bextra (valdecoxib) from the market, pharmaceutical giant Pfizer efficiently set in motion the requisite actions, all the while disagreeing with FDA's conclusions about the prescription anti-inflammatory drug.
'Pfizer has not yet decided to recall, but rather has agreed to suspend marketing,' according to a Food & Drug Administration spokesperson. FDA defines recall as the 'removal or correction of a product actually in the distribution chain.'" [FrontLineToday.com]
Thursday, April 14, 2005
Tuesday, April 12, 2005
DRUG ADS SHOW 'BEXTRA' CAUTION
"The withdrawal of two once-heralded painkillers within months is putting pressure on Big Pharma to take a hard look at its marketing tactics.
"In one prominent example, Johnson & Johnson has altered the tone of a recent campaign for its Ortho Evra birth-control patch to focus on potential medical concerns. One ad shows a doctor warning a young woman about the dangers of a stroke from smoking while on the patch." [New York Post]
"In one prominent example, Johnson & Johnson has altered the tone of a recent campaign for its Ortho Evra birth-control patch to focus on potential medical concerns. One ad shows a doctor warning a young woman about the dangers of a stroke from smoking while on the patch." [New York Post]
Friday, April 08, 2005
FDA Public Health Advisory FDA Announces Important Changes and Additional Warnings for COX-2 Selective�and Non-Selective Non-Steroidal Anti-Inflammato
"Today, the Food and Drug Administration (FDA) is announcing that it has asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide." [FDA Repost @ Alexanderlaw.com]
Thursday, April 07, 2005
Pfizer Pulls the Pin on Bextra
"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
Pfizer Pulls the Pin on Bextra
"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
Pfizer Pulls the Pin on Bextra
"Pfizer (PFE:NYSE - news - research) shares fell Thursday after the drugmaker agreed to a Food and Drug Administration request to withdraw its controversial arthritis drug Bextra.
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
"Regulators also called for a so-called black box warning on the drugmaker's Celebrex, a bigger part of Pfizer's arthritis franchise. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts." [TheStreet.com]
Sanford Bernstein Analyst: Return Of Bextra Unlikely >PFE | newratings.com
"Pfizer Inc.'s (PFE.NYS) withdrawal of its painkiller Bextra was not a total surprise and it is unlikely Bextra will return to the market, said Richard Evans, pharmaceuticals analyst at Sanford Bernstein.
'I think this should be the expected outcome,' Evans told CNBC Thursday.
"Earlier, Pfizer confirmed the U.S. Food and Drug Administration asked it to pull Bextra from the market amid worries of increased cardiovascular risk and to add so-called 'black box' warnings to another painkiller, Celebrex." [NewsRatings.com]
'I think this should be the expected outcome,' Evans told CNBC Thursday.
"Earlier, Pfizer confirmed the U.S. Food and Drug Administration asked it to pull Bextra from the market amid worries of increased cardiovascular risk and to add so-called 'black box' warnings to another painkiller, Celebrex." [NewsRatings.com]
Bloomberg.com: Top Worldwide
"Pfizer Inc., the world's largest drugmaker, dropped after the company suspended sales of its Bextra painkiller." [Bloomberg.com]
FDA tells Pfizer to pull Bextra off market
"Food and Drug Administration officials Thursday told Pfizer Inc. to take its COX-2 drug Bextra off the U.S. market and put a warning on Celebrex." [Scient Daily]
Scotsman.com News - Latest News - Bextra Painkiller Sales Suspended in Europe
"Drugs company Pfizer today agreed to suspend sales of its pain-killing drug Bextra across Europe.
"The announcement is the latest to affect the class of drugs known as COX-2 inhibitors following the withdrawal of Vioxx last year due to concerns over an increased risk of heart attack and stroke." [Scotsman News]
"The announcement is the latest to affect the class of drugs known as COX-2 inhibitors following the withdrawal of Vioxx last year due to concerns over an increased risk of heart attack and stroke." [Scotsman News]
Pfizer Yanks Bextra off Market
"Pfizer withdrew Bextra from the market Thursday after U.S. and European regulators said the arthritis drug’s risks may outweigh its benefits.
"The U.S. Food and Drug Administration also asked the company to put a so-called “black box” warning on its painkiller Celebrex, which is a strong cautionary notice on its use.
"Pfizer said it disagrees with the findings, but would comply with both requests as it pursues further discussions with the FDA. The agency previously advised U.S. physicians to limit prescriptions of both drugs due to evidence they might increase the risk of heart problems and stroke." [Red Herring]
"The U.S. Food and Drug Administration also asked the company to put a so-called “black box” warning on its painkiller Celebrex, which is a strong cautionary notice on its use.
"Pfizer said it disagrees with the findings, but would comply with both requests as it pursues further discussions with the FDA. The agency previously advised U.S. physicians to limit prescriptions of both drugs due to evidence they might increase the risk of heart problems and stroke." [Red Herring]
Pfizer takes painkiller Bextra off market
"The painkiller Bextra was taken off the market Thursday, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them." [BusinessWeek.com]
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