Nov 12, 2008 10:36AM

FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Nov 06, 2008 10:04AM

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Nov 05, 2008 04:31PM

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Oct 31, 2008 09:49AM

FDA Approves Toviaz, a New Drug to Treat Overactive Bladder

The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.

Oct 29, 2008 01:30PM

HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief

Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

Oct 28, 2008 04:59PM

FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report

The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.

Oct 28, 2008 07:15AM

FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

Oct 24, 2008 12:57PM

FDA Approves Lung Valve to Control Some Air Leaks after Surgery

The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.

Oct 16, 2008 01:33PM

FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Oct 15, 2008 01:00PM

FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs

Nov 18, 2008 05:14AM

Local Restaurants Make Deal with Diners: Predictable Affordability

Fixed-cost menus at Blue Sea Grill and Ruth's Chris Steak House aim to offer the usual quality -- at unusual prices

Nov 18, 2008 05:13AM

Carlson Restaurants Worldwide Announces T.G.I. Friday's Executive Appointments

Carlson Restaurants Worldwide, parent company of T.G.I. Friday's restaurants, recently announced two executive promotions, naming John Neitzel President and COO of T.G.I. Friday's USA and Ricky Richardson Executive Vice President and COO of T.G.I. Friday's International.

Nov 18, 2008 05:10AM

Max & Erma's Launches New Menu

Max & Erma's has launched a new, bolder menu in its 106 corporate and franchise stores.

Nov 18, 2008 05:08AM

Pinkberry Announces Northern California Expansion

Announced it will expand throughout Northern California beginning with the opening of a new store in San Jose next month.

Nov 18, 2008 05:07AM

NPD Reports Two out of Three Households Won't Prepare Turkey This Thanksgiving

Only 30 percent of households will actually prepare a turkey on Thanksgiving Day, but 82 percent of consumers eat it, according to The NPD Group, a leading market research company. NPD finds that typically two households are the guest of another household on Turkey Day, which amounts to an average of nine people at each Thanksgiving table.

Nov 18, 2008 04:50AM

Famous Dave's Announces Closure of Atlanta Market and Lease Terminations

Famous Dave's of America, Inc. (NASDAQ: DAVE) today announced it has closed its three restaurants in Atlanta, Georgia as a result of current and expected continuing cash losses from those units. The company continues to have discussions with the landlords of these restaurants regarding a buyout of these leases.

Nov 17, 2008 06:45AM

International Yogurt Company to Open Fifteen Retail Locations in Upstate New York

On November 28th, international frozen yogurt company Yogen Fruz will be opening its first location in Upstate New York at Eastview Mall in Victor, NY. Yogen Fruz will be opening 15 retail locations throughout Upstate New York over the next two years.

Nov 17, 2008 06:44AM

TiVo Adds Domino's Pizza to Its Menu

Domino's is Pioneering a Whole New Way of Ordering ... Via TV

Nov 17, 2008 06:42AM

Johnny Rockets to Cater 2008 American Music Awards After-Party

The Johnny Rockets Group, Inc. today announced the continuation of their partnership with dick clark productions to cater the 2008 American Music Awards After-Party, Sunday, November 23rd, at Nokia Theatre L.A. LIVE in Downtown Los Angeles.

Nov 17, 2008 06:09AM

NexCen Brands Reports Selected Preliminary Third Quarter Operating Results and Highlights

Royalty and other revenue of approximately $7.1 million versus $5.0 million in the third quarter of last year, an increase of approximately $2.1 million or 42%.