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US FDA Approves New Indication for CRESTOR(R) (rosuvastatin calcium)
WILMINGTON, Del., Feb. 8 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved CRESTOR® (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in
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Lupin Receives FDA Approval for Amlodipine/Benazepril Capsules
BALTIMORE, Feb. 8 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already c
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Sagent Pharmaceuticals Announces FDA Approval of Labetalol Hydrochloride Injection, USP
SCHAUMBURG, Ill., Feb. 8 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be availab
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Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
HAYWARD, Calif., Feb. 8 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protoc
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Novus Scientific Receives FDA Clearance for TIGR(TM) Matrix Surgical Mesh - World's 1st Long-Term Resorbable Synthetic Mesh
SINGAPORE, UPPSALA, Sweden and CANTON, Mass., Feb. 5 /PRNewswire/ -- Novus Scientific Pte. Ltd today announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the TIGR™ Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness
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Strativa Pharmaceuticals Provides An Update On Zuplenz(R) (Ondansetron) Oral Soluble Film
WOODCLIFF LAKE, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea a
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FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
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FDA Updates Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.
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Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
PITTSBURGH, Feb. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/1
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First Fractional Laser FDA Cleared for Striae
BURLINGTON, Mass., Feb. 4 /PRNewswire/ -- Palomar Medical Technologies, Inc. is pleased to announce that the Lux1540™ Fractional non-ablative laser handpiece has received the first clearance by the United States Food and Drug Administration (FDA) for the treatment of striae (stretch marks) usi
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Advanced High Throughput Automated Immunoassay Fecal Occult Blood Test (FIT) System Receives FDA Clearance
CORTLANDT MANOR, N.Y., Feb. 4 /PRNewswire/ -- Polymedco, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointe
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United States Seizes more than 1500 Cases of Food from Wisconsin Distribution Warehouse
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
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FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers.
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Patients with Refractory Metastatic Colorectal Cancer
NEW YORK, Feb. 3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, K
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Auxilium Announces U.S. Food and Drug Administration Approval for XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
MALVERN, Pa., Feb. 3 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, just announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first
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BioSpecifics Technologies Corp. Announces FDA Approval of XIAFLEX(TM) for Treatment of Dupuytren's Contracture
LYNBROOK, N.Y., Feb. 2 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, or
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INNOPHARMA Receives First FDA Approval
MONMOUTH JUNCTION, N.J., Feb. 2 /PRNewswire/ -- INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application (ANDA) for ibutilide fumarate injection (the generic equivalent of Corvert® from Pfizer Inc).
As the developer of this generic injectable drug, INNOPHARMA ent
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Veran Medical Receives FDA Clearances to Expand Uses for ig4 Navigation System to Use Ultrasound and 3D Fluoroscopic X-ray
ST LOUIS, Feb. 2 /PRNewswire/ -- Veran Medical Technologies announced today that it has recently received two clearances (K093146 & K093995) from the U.S. Food and Drug Administration (FDA) to expand its indications for use of the ig4 Navigation platform.
The addition of the Ultrasound an
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FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science
The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President's fiscal year 2011 budget – a 23 percent increase over the agency's current $3.28 billion budget.
The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.
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FDA Announces Safety Risk Associated with HIV Drug
The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine).
Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.
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FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries
The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.
Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world.
PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health.
The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.
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FDA Accepts TOPICA'S Luliconazole IND to Begin Clinical Trials in Onychomycosis
PALO ALTO, Calif., Feb. 1 /PRNewswire/ -- TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the use of luliconazole, its lead product candidate, in
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FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.
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GSK's TYKERB(R) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
PHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer
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FDA Expands Use of Approved Breast Cancer Drug
The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.
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FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and
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United States Seizes Unapproved Ozone Generators
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.
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Cancer Medicines Pipeline Offers Patients Great Hope
WASHINGTON, Jan. 29 /PRNewswire-USNewswire/ -- The Bienville Democrat in Arcadia, LA recently reported that America's pharmaceutical research and biotechnology companies have made great progress in treating cancers, introducing many new, breakthrough medicines.
According to the article, scientists
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FDA Announces Class I Recall of Certain Infusion Set Needles
The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.
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FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.
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FDA Approves New Treatment for Type 2 Diabetes
The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.
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FDA Approves First Percutaneous Heart Valve
The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.
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FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.
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FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.
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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients
The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.
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U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in Connection with Unlicensed Cosmetic Treatments
According to testimony at trial and records filed in the case, FAITH
HE used counterfeit Botox© and Restylane© on customers at her
Bellevue beauty salon. FAITH HE was not a medical doctor licensed
to use injectable treatments for wrinkle removal such as Botox and
Restylane.
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FDA Warns Consumers about Counterfeit Alli
The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).
Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.
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FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety
FDA Commissioner Margaret A. Hamburg today sent a letter to America's health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines.
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