Showing posts with label FDA APPROVALS. Show all posts
Showing posts with label FDA APPROVALS. Show all posts

Thursday, July 10, 2014

FDA APPROVES MEDTRONIC COREVALVE SYSTEM

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Medtronic CoreValve System - P130021/S002

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Medtronic CoreValve System
PMA Applicant: Medtronic CoreValve LLC
Address: Medtronic CoreValve LLC, 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: June 12, 2014
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf13/P130021S002a.pdf

What is it? The Medtronic CoreValve System (often referred to as the CoreValve) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of pig tissue attached to a flexible, self-expanding, nickel-titanium frame for support.

How does it work? The CoreValve is compressed and placed on the end of a tube-like device called a delivery catheter. It is then inserted through the femoral artery in the leg. If the femoral arteries are not suitable, the valve can also be inserted through other arteries or through the aorta. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then released from the catheter, it expands on its own, and anchors to the diseased valve. The CoreValve functions the same as a normal valve, helping the blood flow properly by opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The CoreValve is used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of the patients die within two years if the diseased valve is not replaced.

The CoreValve should only be used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? The CoreValve can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but the surgical procedure is highly risky, or too risky. In the U.S. clinical trial, the CoreValve was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. However, implanting the CoreValve also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, and the need for a permanent pacemaker. For some patients with coexisting conditions or diseases, the risks may be especially high. Patients should discuss with their doctors the benefits and risks of this device.

When should it not be used? The CoreValve should not be used in patients who:

have an infection in the heart or elsewhere.
have an artificial (mechanical) aortic valve.
cannot tolerate blood thinning medicines.
have sensitivity to Nitinol (Titanium or Nickel) or to fluid used during the procedure to   see internal structures (contrast media).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Sunday, June 1, 2014

GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA approves first generic versions of celecoxib
May 30, 2014
Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Monday, April 21, 2014

RAGWITEK APPROVED BY FDA FOR SHORT RAGWEED POLLEN ALLERGIES

FDA NEWS RELEASE

For Immediate Release: April 17, 2014


FDA approves Ragwitek for short ragweed pollen allergies 

The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
 
Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.
 
“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. 
 
Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots. 
 
The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo. 
 
The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient.
 
Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.

For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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