Approves in Medical News

FDA Approves New 3000 IU Vial Size for Kogenate(R) FS, antihemophilic factor (recombinant)

WAYNE, N.J., Aug. 7 /PRNewswire/ -- Today, Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a 3000 IU (international unit) vial size of Kogenate(R) FS , antihemophilic factor (recombinant). The new vial size offers greater co...

FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia

MONTGOMERY, Ala. and MORRISVILLE, N.C., Aug. 3 /PRNewswire/ -- Kowa Research Institute (KRI) based in Morrisville, NC and Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. ...

FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

TITUSVILLE, N.J., July 31 /PRNewswire/ -- The U.S. Food and Drug Administration today approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults. It is the first once-monthly, lon...

House Committee Approves Amendment Eliminating Cost-Sharing for Medicaid Preventive Services

Partnership for Prevention Led Coalition Backing Amendment WASHINGTON, July 31 /PRNewswire-USNewswire/ -- The House Energy and Commerce Committee on Friday unanimously approved an amendment to health reform legislation that would prohibit cost-sharing to Medicaid patients f...

FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

SILVER SPRING, Md., July 30 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) announced today that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertensi...

FDA Approves Sculptra(R)Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles

BRIDGEWATER, N.J., July 29 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved Sculptra(R)Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and ...

Kaiser Permanente Approves $11 Million in Community Benefit Grants

OAKLAND, Calif., July 28 /PRNewswire/ -- Kaiser Permanente, one of America's leading health care providers and nonprofit health plans, announced today that it has approved more than $11 million in grants and donations to more than 700 nonprofit agencies nationwide in the second...

FDA Approves Expanded Use of Lilly's FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis

INDIANAPOLIS, July 23 /PRNewswire-FirstCall/ -- Today, Eli Lilly and Company (NYSE: LLY ) announced that the U.S. Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug FORTEO((R)) [teriparatide (rDNA origin) injection] to treat osteoporosis associated...

American Academy of Orthopaedic Surgeons approves new guideline for the treatment of pediatric diaphyseal femur fractures

ROSEMONT, Ill. -- The American Academy of Orthopaedic Surgeons'(AAOS) Board of Directors approved a new clinical practice guideline for the treatment of pediatric diaphyseal femur fractures. Diaphyseal (the shaft of a long bone) fracture of the femur (the bone in the thigh) is a very common childh...

American Academy of Orthopaedic Surgeons Approves New Guideline for the Treatment of Pediatric Diaphyseal Femur Fractures

ROSEMONT, Ill., July 22 /PRNewswire-USNewswire/ -- The American Academy of Orthopaedic Surgeons'(AAOS) Board of Directors approved a new clinical practice guideline for the treatment of pediatric diaphyseal femur fractures . Diaphyseal (the shaft of a long bone) fracture of the femur ...

FDA Approves VITROS(R) Anti-HCV Assay for Use On VITROS 5600(R) Integrated and VITROS 3600(R) Immunodiagnostic Systems

RARITAN, N.J., July 21 /PRNewswire/ -- Ortho Clinical Diagnostics today announced the U.S. Food and Drug Administration (FDA) approval of the VITROS((R)) Anti-HCV assay for use on the VITROS 5600((R)) Integrated and 3600((R)) Immunodiagnostic Systems. This approval marks a maj...

FDA Approves Seasonal Flu Vaccine for 2009-2010

Health experts still working on H1N1 swine flu vaccine, which should be ready by fall MONDAY, July 20 (HealthDay News) -- The U.S. Food and Drug Administration has approved the vaccine to protect against the 2009-2010 seasonal flu, health officials announced Monday. The agency noted...

FDA Approves Boston Scientific's TAXUS(R) Liberte(R) Long Stent

NATICK, Mass., July 16 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS((R)) Liberte((R)) Long Paclitaxel-Eluting Coronary Stent System, a next-generation d...

FDA Approves NovoLog(R) Labeling Update

PRINCETON, N.J., July 15 /PRNewswire-FirstCall/ -- Diabetes patients taking NovoLog((R)) (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to six days following the U.S. Food and Drug Administration (FDA) approval of a labeling change, diabetes care co...

Fitness Management Group, Inc. Approves Sale of the Company

CHARLOTTE, N.C., July 10 /PRNewswire/ -- Fitness Management Group, Inc. (the "Company"), parent company of Peak Fitness Centers ("Peak Fitness"), today announced that the Company has filed a voluntary petition under Chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court for the Western Dis...

Cardinal Health Board of Directors Approves CareFusion Spinoff

DUBLIN, Ohio, July 10 /PRNewswire-FirstCall/ -- Cardinal Health today announced its board of directors has approved the spinoff of CareFusion Corporation through a pro rata distribution of at least 80 percent of the shares of CareFusion common stock to Cardinal Health shareholders, with Cardinal H...

Video: FDA Approves Hologic's Adiana(R) Permanent Contraception System

Adiana system offers safe, simple, effective alternative to tubal ligation BEDFORD, Mass., July 7 /PRNewswire-FirstCall/ -- Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX ), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical pr...

European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application

SEATTLE, July 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it had requested and the EMEA has agreed to an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA) in September, 2009 extending the review for the C...

FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter

PARIS, July 2 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatm...

FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment for Epilepsy

RESEARCH TRIANGLE PARK, N.C. , June 1 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK ) announced today that the U.S. Food and Drug Administration has approved Lamictal(R)XR(TM) (lamotrigine) Extended-Release Tablets as once-a-day add-on therapy for epilepsy patients 13 years of...

FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

- Single infusion of Reclast increases bone mass for two years in postmenopausal women with osteopenia, a condition that can lead to osteoporosis(1) - Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist(2,...

FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia

Once-Daily SAMSCA Increases Serum Sodium Levels Through Increase in Free Water Clearance TOKYO and PRINCETON, N.J., May 21 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced today that the U.S. Food and Drug...

ClearWay Minnesota(SM) Board Approves Four Regional Grants

New grants will serve communities in outstate Minnesota MINNEAPOLIS, May 20 /PRNewswire/ -- Today ClearWay Minnesota's Board of Directors approved four regional grants dedicated to reducing tobacco's harm through coalition building, public education and policy advocacy. The grants will provi...

Department of Defense Approves ISSA as Fitness Education Provider to Military Spouses

CARPINTERIA, Calif., May 14 /PRNewswire/ -- The International Sports Sciences Association (ISSA) announced today that they have been approved by the Department of Defense for the Military Spouse Career Advancement Account (MyCAA) Financial Assistance program. In mid May 2009, MyCAA will offi...

FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes

First and only oral antidiabetic fixed-dose combination medication approved with the extended-release form of metformin DEERFIELD, Ill. and OSAKA, Japan, May 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., t...

Treating Untreatable Brain Tumors: FDA Approves New Laser Surgery

Monteris Medical Earns 510(k) Clearance for AutoLITT(TM) KALAMAZOO, Mich., and WINNIPEG, Manitoba, May 13 /PRNewswire/ -- An MRI-guided laser surgery method, in investigational use at both The Cleveland Clinic and University Hospitals Case Medical Center, holds promise for thousands of brain ...

FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets

- Easy-to-swallow formulation provides important new alternative for patients RESEARCH TRIANGLE PARK, N.C., May 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK ) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal(R) ODT(TM) (lamotrigine) Orally Di...

Video: FDA approves Exforge HCT(R) - the Only High Blood Pressure Treatment to Combine Three Medications in a Single Pill

- Exforge HCT combines a proven calcium channel blocker, angiotensin receptor blocker and diuretic (amlodipine, valsartan, hydrochlorothiazide) in one pill - In a clinical trial, Exforge HCT demonstrated significantly greater reductions in systolic and diastolic BP, compared to all dual comb...

Kaiser Permanente Approves $13 Million in Community Benefit Grants in First Quarter of 2009

Funding Focuses on the Safety Net and Elderly Care in Underserved Communities OAKLAND, Calif., April 28 /PRNewswire/ -- Kaiser Permanente announced today that it has approved more than 400 grants and donations totaling approximately $13 million in the first quarter of 2009. The not-for-profi...

FDA Approves 'Plan B' Pill for 17-Year-Olds

Decision is latest involving controversial birth-control drug WEDNESDAY, April 22 (HealthDay News) -- Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth contr...

AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents

NEW YORK, April 8 /PRNewswire/ -- Adolescence is a challenging time that is full of changes, during which, some teenagers may experience a debilitating illness known as depression. The good news is that depression is treatable. Here's more about a treatment newly approved for adolescents dealing ...

AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents

NEW YORK, April 8 /PRNewswire/ -- Adolescence is a challenging time that is full of changes, during which, some teenagers may experience a debilitating illness known as depression. The good news is that depression is treatable. Here's more about a treatment newly approved for adolescents dealing ...

FDA Approves New Indication for Wyeth's TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

Indication Offers New Option for Adult Patients Suffering From Community-Acquired Bacterial Pneumonia COLLEGEVILLE, Pa., March 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the U.S. Food and Drug Administration (FDA) approved TYG...

U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System

- Integrated System Treats Cutaneous T-cell Lymphoma - EXTON, Pa., March 23 /PRNewswire/ -- Therakos, Inc., a pioneer in immune cell therapy, today announced the U.S. Food and Drug Administration (FDA) approval of the THERAKOS(TM) CELLEX(TM) Photopheresis System for the palliative (reducing t...

FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression

New Indication is One of Three FDA Approvals Spanning Lilly Neuroscience Brands INDIANAPOLIS, March 23 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax(R) (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company (NYS...

FDA Approves Two Hologic HPV Tests

Cervista HPV HR: First FDA approved high-risk HPV test in a decade Cervista HPV 16/18: First HPV DNA genotyping test approved by the FDA BEDFORD, Mass., March 13 /PRNewswire-FirstCall/ -- Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX ), a leading women's healthcare company dedi...

U.S. Food and Drug Administration Approves New Female Condom

Center for Health and Gender Equity Applauds Expansion of HIV Prevention Options for Women and Men Worldwide WASHINGTON, March 11 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) granted regulatory approval to the FC2 female condom, a lower-cost, second generati...

Congress Approves FY2009 Omnibus Appropriations Bill with $900 Million for The Global Fund

Bill Ensures Greater Prevention, Treatment and Care Services for People around the World Affected by AIDS, Tuberculosis and Malaria WASHINGTON, March 11 /PRNewswire-USNewswire/ -- Late yesterday the U.S. Senate voted to pass H.R. 1105, the Omnibus Appropriations bill for fiscal year 2009. ...

FDA approves ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout

Deerfield, Ill., and Osaka, Japan, February 13, 2009 Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC (febuxostat) 40 mg and 80 mg for th...

State Health Department Approves Closure Plan for Brownsville Tri-County Hospital

HARRISBURG, Pa., Feb. 12 /PRNewswire-USNewswire/ -- The Pennsylvania Department of Health has reviewed and approved the plan of closure for Brownsville Tri-County Hospital in Brownsville, Fayette County, which ceased operations today. All 15 patients who were in the hospital have been relocat...