Good Health is Your Greatest Wealth……Virgil
Still, because of additional safety and efficacy testing required by the Food and Drug Administration, U.S. approval may take an extra three to five years after European clearance, said Philip Schauer, a bariatric surgeon at the Cleveland Clinic …
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While Qsymia has indeed been approved for consumption by the Food and Drug Administration, it is often the case that health problems caused by new medications will take some time to surface. The hCG Diet offered by Diet Doc Weight Loss Plans goes was …
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(Reuters) – U.S. health regulators recommended against use of Pfizer Inc’s pulmonary arterial hypertension (PAH) drug Revatio in children up to 17 years of age, saying it had a higher risk of death when taken in a high dose. While the drug has never been approved for treatment of PAH in children, the U.S. Food and Drug Administration’s warning is against off-label use of the drug. …
(Reuters) – The Food and Drug Administration on Thursday approved Ironwood Pharmaceuticals Inc’s drug to treat chronic constipation and irritable bowel syndrome with constipation for use in adults. The drug, linaclotide, will be sold under the brand name Linzess and carry a boxed warning that it should not be used in patients 16 or younger, the agency said. An estimated 63 million people suffer from chronic constipation, according to the National Institutes of Health. Additionally, an estimated 15. …
The Food and Drug Administration announced approval of the first new prescription diet pill in 13 years. The approved drug is known as lorcaserin and … Xenical is rarely used due to modest weight loss results and unpleasant side effects of the …
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(Reuters) – U.S. health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death. The U.S. Food and Drug Administration said the affected pump modules, used for delivering a variety of fluids, drugs and blood products to patients, were manufactured between October 2011 and February 2012. The FDA classified the action as a Class I recall on its website, meaning that the defective units could cause serious harm to a patient’s health. …
We still may be in bathing suit weather, but flu season will be here before we know it. The Food and Drug Administration announced its approved vaccine formula today that covers three strains of influenza.
(Reuters) – Acorda Therapeutics Inc said on Monday that a low-dose version of its multiple sclerosis drug Ampyra did not work in a clinical study, a potentially positive result that will hold generic competition at bay until 2027. A post-marketing study of Ampyra failed to show an improvement in patients’ walking speed when 5 mg of the drug was given twice a day. Had the 5 mg version worked, generic rivals could have entered the market in 2017 or 2018. A 10 mg version of the drug was approved by the U.S. Food and Drug Administration in 2010, and that dose has patent protection until 2027. …
(Reuters) – NPS Pharmaceuticals Inc said U.S. health regulators pushed back the review date for the marketing approval application for its experimental bowel drug by three months. U.S. Food and Drug Administration will now decide on the approval of Gattex on December 30, 2012, the drugmaker said in a statement. The FDA extended the date to provide time for a full review of the submission, NPS Pharmaceuticals said. The application was accepted by the agency in January 2012. …
WASHINGTON (Reuters) – The Food and Drug Administration said on Thursday it has approved Talon Therapeutics Inc’s Marqibo treatment for adults with a rare form of leukemia known as Philadelphia chromosome negative acute lymphoblastic leukemia. The drug, a targeted version of generic chemotherapy drug vincristine, will be the first commercial product for Talon. The company is majority-owned by Warburg Pincus and Deerfield Management, but shares accounting for a minority portion of its equity trade over-the-counter and were down 5 percent in afternoon trading. …
Neither was the U.S. Food and Drug Administration, which declared that all advertisements for HCG injections must include the disclaimer that "this drug was not approved as a safe and effective treatment for weight loss." Still, the fact was … Little …
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Genetic test maker 23andMe is asking the Food and Drug Administration to approve its personalized DNA test in a move that, if successful, could boost acceptance of technology that is viewed skeptically by leading scientists who question its usefulness.