Abbott Laboratories’ weight loss drug Meridia will be reviewed by an advisory panel to the U.S. Food and Drug Administration on Sept. 15, the company said Friday. Get the full story »
Inside these posts: FDA
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Use of Viagra form for kids’ lung disease weighed
From Bloomberg News | Only devising a test protocol stands in the way of a version of Pfizer’s Viagra being used to treat a rare lung disorder in children. A Food and Drug Administration panel will meet Thursday to discuss it.
PhRMA wants better FDA explanation on drug risk
The Food and Drug Administration should better explain its reasons whenever it requires additional safeguards for risky drugs, a pharmaceutical industry group said Monday.
That recommendation is one of dozens expected this week at a public meeting on the FDA’s risk evaluation and mitigation strategies, or REMS, a set of tools to protect consumers from drugs with potentially serious side effects. Get the full story »
FDA warns Abbott on glucose monitors
The U.S. Food and Drug Administration has warned Abbott Laboratories’ diabetes care unit about manufacturing problems at its Alameda, California plant, a letter released Tuesday said.
In a letter dated July 2, FDA said its inspectors found Abbott’s Freestyle and Navigator blood glucose monitoring products were adulturated and not conforming with codes for good quality system manufacturing practices. Get the full story »
FDA questions Roche’s Avastin for breast cancer
The Food and Drug Administration questioned the benefit of using Roche Holding AG’s top-selling cancer drug, Avastin, in breast cancer.
The agency said the magnitude of an improvement seen among women being treated with chemotherapy drugs plus Avastin compared with women being given chemotherapy alone “is not clinically meaningful.” The agency also said there were more serious side effects such as bleeding seen among women being given Avastin. Get the full story »
Panel votes to keep Avandia on market
U.S. health advisers said GlaxoSmithKline Plc’s diabetes drug Avandia should be allowed to stay on the market in some form, easing a threat of further litigation that could have followed a ban.
Twenty of the 33-member panel of outside experts convened by the Food and Drug Administration voted for various options that would allow Avandia to stay on the market despite concerns over associated heart risks. Get the full story »
Baxter told to step up pump recall efforts
The U.S. Food and Drug Administration today said Baxter International Inc. needs to take several steps designed to follow through on a recall of its Colleague infusion pumps including providing customers with a “a refund, a replacement pump, or lease termination.” Get the full story »
Glaxo defends Avandia in hearings on drug’s safety
GlaxoSmithKline Plc insisted its diabetes pill Avandia was safe as U.S. advisers began a two-day meeting to consider whether the medicine is too dangerous to stay on the market.
The scientific experts assembled by the Food and Drug Administration are sorting through sharply conflicting data on whether Avandia causes heart attacks. Get the full story »
FDA tells of generic competition for Latisse
An unnamed drug maker has applied for U.S. regulatory approval to sell a generic version of Allergan Inc.’s eyelash-enhancing drug Latisse before its patent protection expires.
Latisse, approved in late 2008 with $73.3 million in sales last year, has market exclusivity until late 2011. But the Food and Drug Administration disclosed last week that a company filed an application in May to market a copycat version by challenging Allergan’s patent for the drug. The FDA didn’t identify the applicant of the generic drug. Get the full story »
APP to market breast cancer treatment
Schaumburg-based APP Pharmaceuticals Inc. will begin marketing a breast cancer treatment medication in the U.S. as Anastrozole, the drug’s generic name. Anastrozole tablets, also known as Arimidex , are mainly used to treat early breast cancer in post-menopausal women.
APP’s parent company, Fresenius Kabi Pharmaceuticals Holding Inc., said the move comes after the U.S. Food and Drug Administration granted its research company permission to market the drug.
June 28, 2010 at 2:56 p.m.
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Filed under: Lightly salted Fritos, Ruffles go nationwide
Frito-Lay announced Monday it will begin selling two lightly salted chips brands nationwide.
The announcement comes three months after Frito-Lay’s parent, PepsiCo Inc., pledged to reduce sodium in each serving of its key brands by one-fourth in five years. Fritos lightly salted corn chips and Ruffles lightly salted potato chips have been on sale in select markets since 2000.
Frito-Lay says the chips have at least 50 percent less sodium per one ounce serving than the original chips. On average, Americans consume 3,436 mg of sodium, 1,136 mg more than the FDA’s daily guideline.
Abbott gets OK for gonorrhea/chlamydia test
Abbott Laboratories said Monday that the Food and Drug Administration approved a new diagnostic test that allows for the detection of two sexually transmitted diseases.
Abbott’s RealTime Chlamydia trachomatis/neisseria gonorrhoeae (CT/NG) assay and Abbott’s m2000 System can detect gonorrhea and chlamydia, a disease that often goes untreated because of its lack of symptoms. Get the full story »
Studies link diabetes drug Avandia with heart risks
Two studies released Monday reported serious heart risks with GlaxoSmithKline Plc diabetes pill Avandia as U.S. regulators decide whether the drug should stay on the market.
An analysis of 56 clinical trials found Avandia increased the chances of a heart attack by 28 percent to 39 percent, researchers at the Cleveland Clinic in Ohio reported in an update to a 2007 study that sparked intense debate about the drug. Get the full story »
Abbott MS treatment in final clinical trial stage
Abbott Laboratories and its Massachusetts biotech partner have launched a final-stage clinical trial of their experimental treatment for multiple sclerosis.
The first patient — out of 1,500 needed worldwide — was enrolled last month in the U.S. The drug, daclizumab, is being developed for monthly injection under the patient’s skin by North Chicago-based Abbott and Cambridge-based Biogen Idec. Get the full story »
Pfizer to pull leukemia treatment
Drugmaker Pfizer Inc. is pulling a decade-old leukemia medicine off the U.S. market after a study found a higher death rate and no benefit for patients.
Mylotarg won approval under an abbreviated process to help bring treatments for serious diseases to patients more quickly. Medicines cleared in that way must pass follow-up tests to confirm they work. Get the full story »
