FDA panel says Vioxx can go back to market
A company spokeswoman said Merck would not comment on the vote. Pfizer officials put out a press release late Friday.
>>>>PFE ist aus chartt. Gründen für kurzfristige Zocker evtl. interessanter (aber: sehr niedriges Short-Ratio).<<<<
Auszug:
WASHINGTON (MarketWatch) - A U.S. Food and Drug Administration advisory panel narrowly agreed Friday that Merck's recalled drug Vioxx was safe enough to return to the market, and gave the regulatory green light to Pfizer's Celebrex and Bextra.
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The panel voted 17-15 to allow Vioxx to come back to pharmacy shelves, but only if it bears a stern "black box" warning advising users that it can cause heart trouble in patients at risk of developing cardiac problems.
Likewise, the FDA panel also recommended upholding the market approvals for Pfizer's Celebrex and Bextra. Those pain medications will carry similar "black box" warnings.
Because of the proposed black box warnings, the FDA will discourage both Pfizer (PFE: news, chart, profile) and Merck (MRK: news, chart, profile) from doing any direct consumer advertising for the drugs.
Merck officials told the FDA panel on Thursday that it would consider relaunching the drug if the FDA did not rescind its marketing approval. Merck had pulled Vioxx abruptly from the market on Sept. 30 over concerns that long-term use could lead to heart attack or stroke in some patients.
After the vote, FDA panel members advised caution in prescribing the drugs. Agency officials said decisions on how the black box warnings will be worded will be made within the next few weeks.
While the votes cast Friday are not final regulatory decisions, the FDA generally always follows the recommendations of its advisory panels. Details of the "black box" warnings will be worked out at a later date.
The panel also voted to slap a tentative warning on almost 20 non-steroidal anti-inflammatory drugs, known as NSAIDs, advising users that no definitive studies have been conducted to determine if long-term use can cause cardiovascular problems. The drug group includes such popular over-the-counter medications as ibuprofen and naproxen.
Because many NSAIDs have been on the market for decades and now are sold generically, members of the advisory panel admitted it will be difficult to find companies to conduct long-term studies on the drugs. The FDA may therefore consider running its own studies or request they be sponsored by the National Institutes of Health.
The news sent Merck shares skyward, with the stock closing up 13 percent to $32.61 at the close. Shares of Pfizer (PFE: news, chart, profile) jumped 7 percent to close at $26.80.
A company spokeswoman said Merck would not comment on the vote. Pfizer officials put out a press release late Friday.
Ich halte mal fest:
MRK§Feb 18 32.61 +3.76 +13.03%
PFE§Feb 18 26.80 +1.74 +6.94%
Schau'n wir uns das Ganze mal in 3 Monaten an.
Chance MRK +40%
Chance PFE +30%
