FDA weighs over-the-counter Plan B sales
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The government is considering allowing over-the-counter sales of the morning-after pill to women 18 and older &#151; a surprise move Monday that revives efforts to widen access to the emergency contraceptive almost a year after it was thought doomed.
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The difference between a pill and a capsule might not seem big, but it could result in hundreds of millions of dollars in lost sales for Wyeth's top drug.
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The maker of the morning-after pill said it received assurances Tuesday that the government would quickly settle a three-year battle to sell the emergency contraceptive without a prescription to at least some women.
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The US Food and Drug Administration is considering further regulatory measures, including withdrawal from the market, of Pfizer&#39;s arthritis treatment Celebrex.
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Three months after the Food and Drug Administration decided that emergency contraception should be available to women 18 and older without a doctor's prescription, the over-the-counter version of Plan B -- the "morning after" pill -- began appearing in drugstores nationwide last week. Manufacturer Barr Pharmaceuticals shipped the drug after repackaging it to meet federal labeling rules for OTC medications, but as of Friday, some Washington-area stores had yet to receive it....
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Federal health officials cautioned Tuesday the tens of millions of Americans who take popular over-the-counter pain pills of their potentially serious side effects and released planned label changes intended to warn of the sometimes deadly risks.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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FDA could make a decision within days on whether to adopt an advisory panel&#39;s recommendations to include a black box warning about the increased risk of suicidal tendencies that antidepressants pose for children, and any labeling changes could be
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A month after distribution began, the over-the-counter version of the morning-after pill is now available at pharmacies nationwide. Planned Parenthood celebrated yesterday with a free giveaway of the emergency contraceptive, while critics insisted that Plan B's accessibility will soon be a cause for regret.
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A warning is out from the Food and Drug Administration about the pain killer Aleve. The FDA says people taking the over-the-counter medication should strictly follow the directions on the label.
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U.S. health officials on Thursday  approved over-the-counter sales for an at-home heart  defibrillator that proponents hope will save more people from  sudden cardiac death.
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Federal advisers today and tomorrow will consider whether the Food and Drug Administration should approve Merck &amp; Co.'s bid to make Mevacor the first of a class of hot-selling cholesterol-lowering drugs called statins to be sold over the counter.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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U.S. health officials urged doctors  on Friday to consider prescribing alternatives to Pfizer Inc.'s   arthritis drug Celebrex while regulators weigh new data on  heart risks.
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India and China, countries where the Food and Drug Administration rarely conducts quality-control inspections, have become major suppliers of low-cost drugs and drug ingredients to American consumers. Analysts say their products are becoming pervasive in the generic and over-the-counter marketplace.
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Merck next month will make its second try for approval to sell cholesterol drug Mevacor without a prescription. If the Food and Drug Administration approves, cholesterol drugs would
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Dec. 19--Pfizer, the world&#39;s biggest drug maker, and the rest of the pharmaceutical sector will come under renewed pressure this week after the Food and Drug Administration (FDA) warned doctors to consider