Latest US Food and Drug Administration Stories

SAN DIEGO and WOODCLIFF LAKE, N.J., Jan. 3, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA). Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index,...

MDLSV now offering Xeomin for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines), months before the full national release, due to the elite status and extensive experience of MDLSV’s physicians. Baltimore, MD (PRWEB) December 30, 2011 MDLSV now offering Xeomin for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines), months before the full national release, due to the elite status and extensive...

It has been discovered that the US Food and Drug Administration (FDA) has known about problems with French breast implant manufacturer Poly Implant Prothese (PIP) at La Seyne Sur Mer, since sending an investigator in May, 2000. The FDA then sent a letter to the company’s founder Jean-Claude Mas stating that the company had “adulterated” the implants and citing at least 11 other deviations from good manufacturing practices. The problems in 2000 dealt with the company’s line of...

EAST HANOVER, N.J., Dec. 2, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases. The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held from December 6-10, will feature data presentations from...

A ruling and injunction by District Judge Richard Leon blocking tobacco companies from being forced to display graphic images on cigarette packs and advertising, was appealed on Tuesday by the US Food and Drug Administration (FDA). Judge Leon, in the widely expected ruling, said the tobacco companies would likely succeed in their challenge to the new warnings as unconstitutional because it compels speech in violation of the First Amendment and would cause them irreparable harm if not...

The US Food and Drug Administration (USDA) recently officially approved DNA barcoding for seafood in hopes of preventing the growing issue of the mislabeling, both locally produced and imported, into the United States, Rod McGuirk of the Associated Press (AP) reports. Regulators from other countries are also considering adopting DNA barcoding as a cost-effective and highly reliable tool for identifying organic matter. The barcoding of DNA is essentially a standardized fingerprint that can...

SYDNEY and BEDMINSTER, N.J., Nov. 8, 2011 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it received written acceptance from the United States Food and Drug Administration (FDA) for review of the MoxDuo IR New Drug Application (NDA) filed earlier this year. The FDA also set June 25, 2012 as the PDUFA (Prescription Drug User Fee Act) target date for action on the approval of the MoxDuo IR NDA. "We are extremely pleased with this important milestone...

The Centers for Disease Control and Prevention (CDC) said in its latest bulletin yesterday that the number of deaths linked to Colorado-grown cantaloupes tainted with listeria has risen to 29 and 139 people infected across 28 states, Fox News is reporting. Eight deaths have been reported in Colorado; five in New Mexico; three in Kansas; two each in Texas, New York, Missouri and Louisiana; and one each in Indiana, Maryland, Nebraska, Oklahoma and Wyoming. Additionally, a pregnant woman...

American Botanical Council, American Herbal Pharmacopoeia, and University of Mississippi's National Center for Natural Product Research Join Forces to Educate on Supplement Adulteration Problems, Challenges, and Solutions AUSTIN, Texas, Nov. 2, 2011 /PRNewswire-USNewswire/ -- Three leading nonprofit organizations - the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi's National Center for Natural Products Research...

NEW YORK, Oct. 19, 2011 /PRNewswire/ -- It is well known that ophthalmologists around the world often prescribe Avastin (bevacizumab) off-label for wet age-related macular degeneration (AMD) over the approved treatment Lucentis (ranibizumabintravitreal) due to cost and the belief that the two have similar efficacy. AMD Alliance International (AMDAI) is calling for ophthalmologists to stop this practice in light of a concerning surge in eye infections over the past month in patients being...