FDA Sets Deadline for Unapproved Medications
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Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medications, health officials said yesterday.
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Industry analysts are predicting US regulators this month will refuse to approve Merck &amp; Co.&#39;s new arthritis drug until at least 2006 because of heart attacks linked to its recalled sister drug Vioxx.
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WASHINGTON - A new Food and Drug Administration analysis backs earlier suggestions of a link between at least some antidepressants used by children and suicidal tendencies, prompting the agency to prepare new warnings.    Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to FDA documents released Friday...
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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U.S. regulators have asked for more data  on Novartis AG's  diabetes drug Galvus, possibly  delaying approval of the potential blockbuster by a year, which  dented its shares while boosting its main rival's.
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The US Food and Drug Administration is pushing for an expanded review of MDS Pharma&#39;s generic drug studies at its Montreal laboratories, and has requested a meeting with the company to discuss its concerns.
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Pfizer Inc. is on schedule to complete the filing of 20 new drug applications by the end of 2006 as it confronts patent expirations affecting $14 billion in sales, CEO Hank McKinnell said Tuesday.
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Because of PfizerÂs failed trial, drugs similar to torcetrapib from other companies could face greater scrutiny Â and delays Â in getting to market.
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WASHINGTON Sept. 24, 2004 - The Food and Drug Administration &quot;within a few days&quot; will decide on a stronger warning for antidepressants, a top official told Congress.
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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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THURSDAY, June 21 (HealthDay News) -- A programmable device that allows professional caregivers to monitor how patients dispense their medications has been approved by the U.S. Food and Drug Administration, the agency said Thursday.
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It takes another run at getting FDA approval for its lead drug.
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The FDA has another delay for this HPV vaccine.
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The regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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A day late and possibly several millions of dollars short. That's the scenario facing one drug manufacturer unless it can get a helping hand from Congress.
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Genentech said that approval of its colon cancer drug Avastin as a treatment for breast cancer would be delayed by at least a year.
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It'll be awhile before the FDA makes its decision and the stock price settles down.