FDA

FDA To Look Into Safety of Caffeinated Alcoholic Beverages; Agency Sends Letters to Nearly 30 Manufacturers

Docuticker (Free subscription) | 11/23/2009

FDA To Look Into Safety of Caffeinated Alcoholic Beverages; Agency Sends Letters to Nearly 30 Manufacturers Source: U.S. Food and Drug Administration The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products. “The increasing popularity of consumption of caffeinated alcoholic...

Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo(R) Complete Response Letter

PR News Wire (Free subscription) | yesterday

POINT RICHMOND, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response...

ARCA Receives FDA Fast Track Designation for GencaroTM Development in Genotype-Defined Heart Failure Population

Business Wire (Free subscription) | yesterday

BROOMFIELD, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq:ABIO) today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM, the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in...

ADA Petitions FDA To Classify Tooth-Whiteners

HAPPI Breaking News (Free subscription) | yesterday

The American Dental Association (ADA) has asked U.S. Food and Drug Administration (FDA) to establish appropriate classifications for tooth-whitening chemicals. Citing concern about the safety of whitening products that are often administered without the benefit of professional consultation or examination by a dentist, the ADA said that the application of chemically-based tooth whitening or bleaching...

• Molars, incisors and canines -- oh, my! - Booster Shots

Pfizer Receives FDA Approval For Geodon(R) (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults

Medical News Today (Free subscription) | yesterday

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar...

• Pfizer Receives FDA Approval For Geodon® For The Adjunctive Maintenance Treatment Of Bipolar Disorder - Real World of Bipolar
• Pfizer Gains Approval For Geodon Adjunct Therapy - Contract Pharma Breaking News

FDA Recalls Dietary Supplement

A Georgia Lawyer (Free subscription) | yesterday

The FDA recalled three types of dietary supplements known as RockHard Weekend after the supplements were found to contain ingredients related to the active ingredients found in Viagra. The ingredient, sulfoaildenfil, was not listed by the company on the packaging label. Sulfoaildenfil could cause serious injury or even death in some individuals. Sulfoaildenfil may interact with nitrates, an ingredient...

Meridia May Raise Risk of Heart Attacks, Strokes and Death, FDA Says

NewsInferno (Free subscription) | yesterday

Meridia, Abbott Labs’ popular prescription weight loss medication, may be associated with a higher risk of heart-related side-effects, including heart attacks, strokes and death. Over the weekend, the U.S. Food & Drug Administration (FDA) issued a Meridia Early Communication, and said it was reviewing preliminary data from a recent study that indicated patients [...]

FDA Extends NDA Review For Exalgo™ Extended-Release Tablets

Medical News Today (Free subscription) | yesterday

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

FDA Approves Intravenous Formulation Of Pfizer's Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Medical News Today (Free subscription) | yesterday

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

Dendreon must wait to May next year to hear FDA decision on Provenge

thepharmaletter.com (Free subscription) | yesterday

US biotechnology firm Dendreon says that the US Food and Drug Administration as provided written acknowledgement that the company's amended Biologics License Application for Provenge (sipuleucel-T) is a complete response and the agency has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking approval of the...

FDA says heartburn drugs can interfere with Plavix

Fitness Watch (Free subscription) | yesterday

Yet another reason to stay/get fit . "Federal health officials said Tuesday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke. The Food and Drug Administration said the stomach-soothing drugs Prilosec and Nexium cut in half the blood-thinning effect of Plavix, known generically...

FDA approves Pennsaid(R) Topical Solution

Foreign Pharmacy News and Events Section -... (Free subscription) | 11/23/2009

a leading global provider of healthcare products, and Nuvo Research Inc. (TSX:NRI), a Canadian drug development company, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid Topical.

Price Drop: Rx Guide Pro (medical)

AppShopper.com: Price Changes (Free subscription) | 5 hours ago

Rx Guide Pro 1.5 Category: Medical Price: $1.99 -> $0.99 ( iTunes ) Description: ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ What's in your wallet? Instant access to 5,000 FDA approved package inserts plus generic drug for brand name. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Rx Guide Pro is designed to help medical professionals to make clinical decisions more promptly and confidently. Rx Guide Pro contains...

BridgePoint Medical receives European approval for devices

bizjournals (Free subscription) | yesterday

BridgePoint Medical Inc. announced Monday that it has received approval to sell and use its new catheter devices in Europe. The Plymouth-based medical-technology company earned the European CE Mark, the European equivalent of the U.S. Food and Drug Administration’s (FDA) seal of approval, to market its CrossBoss CTO Crossing Catheter and the Stingray CTO Re-Entry System. A recent medical trial...

Bristol-Myers Receives Approval for Autism Drug

SeekingAlpha.com (Free subscription) | yesterday

Zacks.com submits: Recently, Bristol-Myers Squibb Co. ( BMY ) received approval from the U.S. Food and Drug Administration (FDA) to market Abilify (aripiprazole) for the treatment of irritability in pediatric patients having autistic disorder. Abilify can be used to treat children aged 6 to 17 years for symptoms of aggression toward others, deliberate self injury, temper tantrums and quick mood swings....

• US FDA clears new indications for B-MS/Otsuka’s Abilify and Pfizer’s Geodon - thepharmaletter.com

colonic hydrotherapy

jhon8125 | 11/16/2009

http://www.colonichydrotherapy.net There are so many ways of burning fat but do you know what’s the healthiest and easiest way how? A fast and easy way to lose fat is through colon cleansing. Colon cleansing is the removal of fecal wastes and unidentified toxins from the colon and intestinal tract. A form of colon cleansing is colonic hydrotherapy which is supposed to remove toxins in the body. However...

Get Relief from Chronic Pain - Buy Tramadol Online at OnlineTramadol.ws

backpainmedication | 11/08/2009

We've heard about all the great benefits when buy tramadol online: best prices, fast FedEx delivery the following day, and easy-prescription approval (if any at all). But with this great convenience is some risk of a possible disaster and catastrophe. So how do we avoid these risks, yet keep the benefits associated with online pharmacies? Quality pain reliever - tramadol online Since there are many...

Xenical over the counter diet pill, Diet pill that you can believe

jwilliam.j123 | 10/27/2009

Excess weight is a concern of health shared by many of us, but few are able to get rid of him. Xenical, which works on the principle of blocking the suction of some fat in the body helping to find an effective solution for your health problems. Used as a treatment for obesity and weight maintenance benefits, including a low fat diet and regular exercise regime. The creation of Roche is available by...