FDA Newswatch

Food and Drug News for February 22, 2012

FDA Moves to Head Off Shortages of 2 Cancer Drugs
Methotrexate highly effective against childhood leukemia; Doxil treats ovarian cancer TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply. One of the drugs, methotrexate, is used in combination with other drugs to combat -- ...
MSN - 2012-02-21 13:00:27

FDA Approves Korlym for Patients with Endogenous Cushings Syndrome
Media Inquiries: Morgan Liscinsky, 301-796-0397; morgan.liscinsky@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves Korlym for patients with endogenous Cushing's syndrome Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing's syndrome. This drug was approved for use in patients ...
Oncology Business Review - 2012-02-21 14:55:22

FDA to Review Inhalable Caffeine
Get the latest product design news and headlines - Sign up now! Digg Delicious Google It furl It Technorati Email Print [-] Text [+] U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement. AeroShot went on the market late last month in Massachusetts ...
Product Design and Development - 2012-02-21 16:31:09

FDA Halts GTx, Inc. (GTXI)'s Capesaris Trials Due to Blood-Clotting Risk; Stock Sinks -1.9599 (33.79%)
MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the fourth quarter and full year 2011. 'Today, in a separate news release, we announced that following our request to discuss changes in our clinical development program because of dose related safety involving venous thromboembolic events, FDA notified the Company in a telephone ...
Kansas Medical Device Resumes - 2012-02-21 18:12:46

FDA To Give Controversial Diet Drug Another Look
NEW YORK (CBS NEWS) - It's been 13 years since the Food and Drug Administration approved a prescription diet pill. On Wednesday, it takes a second look at a drug called Qnexa, a combination of the drugs phentermine, a stimulant, and topiramate, a seizure or migraine medication. Dr. Judith Korner, director of Columbia University's Weight Control Center, said the drug, according to the most recent ...
CBS Dallas / Fort Worth - 2012-02-21 13:40:48

FDA Endocrinologic & Metabolic Drugs Advisory Committee to hold a meeting
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IC Places - 2012-02-21 16:58:33

New technology pushes introduction of genetically engineered salmon into the U.S. food supply
Genetically engineered animals delivered straight to our plate. Orwellian much? Not anymore. Genetically engineered has moved from the turf to the surf. AquaBounty Technologies, a biotechnology company, developed the first engineered animal meant for consumption. After 15 years, it is waiting for approval of AquAdvantage, an Atlantic salmon that is modified with genes from the Pacific Chinook salmon ...
Daily Sundial - 2012-02-21 14:27:11

FDA staff oppose Chelsea's Northera, shares fall
FDA staff oppose Chelsea's Northera, shares fall Chicago News.Net Share this page A review by Food and Drug Administration staff said the treatment, known generically as droxidopa, had not demonstrated durable effectiveness in clinical trials and showed "worrisome" safety signals in test results and post-marketing cases in Japan. ... Read the full story at Reuters Share this page Have your say on ...
Chicago News.Net - 2012-02-21 16:53:29

Quebec plant fixes force Sandoz to slash output
The U.S. isn't the only country staring down the barrel of a drug shortage. Canada is facing multiple supply problems, now that a Sandoz plant in Quebec has scaled back production, CBC News reports. The generics division of Novartis ( $NVS ) is suspending output of some products and cutting back on others as it works to fix manufacturing violations flagged by the FDA. "As we progress with our remediation ...
FiercePharma - 2012-02-21 17:48:51

Diabetes: Medtronic aims to grab market share with 1st U.S. heart stent for diabetics
Medtronic touts an FDA win for its Resolute Integrity drug-eluting stent as the first heart disease treatment on the U.S. market for patients with diabetes. Medtronic landed a significant win with the announcement of an FDA win for its Resolute Integrity drug-eluting stent, the first device on the U.S. market cleared for patients with coronary artery disease as well as diabetes. Diabetic patients make ...
MassDevice - 2012-02-21 15:03:20