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A recall has been ordered for a high-profile diabetes drug after producers discovered it contained alarmingly high levels of a cancer-causing impurity. Marksans Pharma Limited has recalled ...
Metformin is a medication in a class of compounds called biguanides, according to the U.S. National Library of Medicine. These medications reduce the amount of glucose the body absorbs from food ...
Metformin was approved in Canada in 1972, [6] but did not receive approval by the U.S. Food and Drug Administration (FDA) for type 2 diabetes until 1994. [170] Produced under license by Bristol-Myers Squibb , Glucophage was the first branded formulation of metformin to be marketed in the U.S., beginning on 3 March 1995. [ 171 ]
Whether you’re taking metformin for weight loss, type 2 diabetes, prediabetes, polycystic ovary syndrome (PCOS), or another medical condition entirely, you want to get the most out of your ...
Where risks or harms is the reason for withdrawal, this will usually have been prompted by unexpected adverse effects that were not detected during Phase III clinical trials, i.e. they were only made apparent from postmarketing surveillance data collected from the wider community over longer periods of time. This list is not limited to drugs ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
Metformin — a biguanide — is an oral diabetes medication that helps keep blood sugar in check by causing the liver to produce less glucose. It was approved by the FDA in 1994 for the treatment ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.