Protecting human subjects focus of national FDA conference at UH
HOUSTON, March 17, 2005 New medical devices have to be tested on human subjects, but protecting the rights of those subjects can present considerable challenges for researchers. A national conference devoted to exploring the FDA critical pathway for approval of new medical products while protecting human subjects, co-sponsored by the Food and Drug Administration and the University of Houston, w...GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix
PHILADELPHIA, PA, March 15, 2005 GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine candidate, BoostrixTM [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a unanimous favorable recommendation from the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA). Currently, there...SAM on the favorable recommendation by FDA Advisory Committee for Boostrix
BLUE SPRINGS, MO March 15, 2005 The Society for Adolescent Medicine supports the unanimous favorable recommendation of the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) regarding the development of a vaccine to prevent the occurrence of pertussis in adolescents. We believe that the development of this vaccine will further the health...NYU'S Duster cautions against FDA approval of 'race-based' pharmaceutical
New York University Sociologist Troy Duster concludes that a pharmaceutical to combat heart disease among blacks is based on faulty research and urges the Food and Drug Administration to obtain more reliable data before approving the drug. Duster, president of the American Sociological Association, writes that research on isosorbide dinitrate and hydralazine (BiDil), produced by NitroMed, incorre...Novartis receives FDA approval for Starlix, a new treatment for type 2 diabetes
. . . . .EAST HANOVER, N.J., December 22, 2000 Novartis Pharmaceuticals Corporation today received marketing approval from the U.S. Food and Drug Administration (FDA) for Starlix (nateglinide) for the treatment of type 2 diabetes, a disease with serious consequences that is increasing at an alarming rate among Americans. Starlix, a D-phenylalanine (amino-acid) derivative, is the first in a new...US FDA grants full approval to DOXIL(R) following submission of phase III data
Bridgewater, N.J. February 7, 2005 -- The U.S. Food and Drug Administration (FDA) has granted full approval to DOXIL (doxorubicin HCl liposome injection) for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. DOXIL, marketed in the United States by Tibotec Therapeutics, Division of Ortho Biotech Products, L.P., originally re...Orqis receives FDA approval to expand clinical trial of Cancion CRS therapy to 40 centers
Orqis Medical Corp. today announced that the U.S. Food and Drug Administration has approved an expansion of the Cancion CRS ...The Cancion CRS therapy is a percutaneous cardiac recovery system being studied for its ability to create a "rest-to-recovery" environment for congestive heart failure (CHF) patients. Enrollment in the Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment...FDA approves Pfizer's Lyrica for the treatment of the two most common forms of neuropathic pain
NEW YORK, December 31, 2004 - Pfizer Inc said today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Lyrica (pregabalin capsules) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). Lyrica is the first FDA-approved treatment for both of these neuropathic pain states, which are distin...BMJ turns missing murder case documents over to FDA
The BMJ has turned over confidential drug company documents that went missing from a 10 year old murder case to the US Food and Drug Administration (FDA) for review....... The documents, which were sent to the BMJ by an anonymous source, appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence. They also suggest that Eli Lilly officials w...Pfizer's antifungal medicine VFEND receives FDA approval
NEW YORK, December 28, 2004 Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved the use of its extended-spectrum antifungal VFEND (voriconazole; IV for injection, tablets, and oral suspension) for the treatment of candidemia in nonneutropenic patients (those without low white blood cell counts) and the following Candida infections: disseminated (deep tissue) infe...OHSU researcher says FDA could broaden access to results of clinical drug trials
A researcher at Oregon Health & Science University and the Portland Veterans Affairs Medical Center is calling upon the U.S. Food and Drug Administration (FDA) to share more information provided by pharmaceutical companies regarding their clinical drug trials. This database could be freely accessible to health care providers, researchers and the public. Such a move would be cost-effective and cou...FDA approves Enablex for treatment of overactive bladder
East Hanover, December 22, 2004 Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Enablex (darifenacin) extended-release tablets (7.5mg and 15mg) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. Enablex, a once-daily medication, is expected to launch in the U.S. in ea...Shire receives US FDA approval of EQUETRO (TM) for bipolar disorder
BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, December 13 -- Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that the US Food & Drug Administration (FDA) has approved EQUETRO(TM) (extended-release carbamazepine capsules), previously known as SPD417, for the treatment of patients with Bipolar Disorder, ten months after submission. ...... Bipolar Disorder is one...Testosterone patch will test FDA's decision making
The Food and Drug Administration (FDA) has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient data and potentially misleading marketing by their manufacturer Proctor & Gamble, claim two articles in this week's BMJ.... ...The patch is the first drug to be assessed for a controversial condition called hypoactive sexual desire diso...FDA tried to discredit whistleblower over drug safety claims
The Food and Drug Administration (FDA) tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today.... ...Dr David Graham, Associate Director in the FDA's Office of Drug Safety, said that the FDA was "incapable of protecting America against another Viox...FDA grants accelerated approval of TYSABRI, formerly antegren, for the treatment of MS
... ...Cambridge, MA; San Diego, CA; Dublin, Ireland November 23, 2004 Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the U.S. Food and Drug Administration (FDA) has approved TYSABRI (natalizumab), formerly referred to as ANTEGREN, as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses. FDA granted Accel...FDA buys technology that identifies drug toxicity to heart
The University of Rochester Medical Center has a new tool to assess whether a medication might be harmful to the heart. The technology addresses a major health issue drug toxicity illustrated most recently by Merck's voluntary withdrawal of Vioxx from the market after concerns that it may cause heart attacks and strokes....... Jean-Philippe Couderc, a biomedical engineer, developed a...FDA approves Fosrenol(R) in end-stage renal disease (ESRD) patients
Basingstoke, UK, 27 October 2004 The U.S. Food and Drug Administration (FDA) today approved FOSRENOL (lanthanum carbonate), a new non-calcium, non-aluminium phosphate binder that reduces high serum phosphate levels in patients with end-stage renal disease (ESRD)....... Without effective treatment, this condition often leads to renal osteodystrophy, a collection of bone diseases that causes bo...Intranasal corticosteroid receives FDA pregnancy Category B rating for allergic rhinitis
Wilmington, DE August 26, 2004 AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved revised labeling for its anti-inflammatory corticosteroid nasal spray RHINOCORT AQUA (budesonide). The new labeling upgrades RHINOCORT AQUA's pregnancy rating to Category B for the treatment of allergic rhinitis. ... ...The achievement of a Category B rating indicates that...FDA approves Adderall XR (R) to treat ADHD in adults
Philadelphia, Pa. Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR® (mixed salts of a single-entity amphetamine) as a once-daily treatment for adults with Attention Deficit Hyperactivity Disorder (ADHD). Since 2001, ADDERALL XR has been approved in the U.S. for the treatment of ADHD in...Research Triangle Park, NC August 2, 2004 - EPZICOM , a new product combining two HIV medicines into one tablet dosed once a day (QD) with no food or fluid requirements, was cleared for prescription use today by the U.S. Food and Drug Administration (FDA). EPZICOM combines two widely-used nucleoside reverse transcriptase inhibitors (NRTIs), EPIVIR(R) (lamivudine, 3TC) and ZIAGEN(R) (abacavir sul...FDA approves new labelling for Seroquel in bioplar mania
Alderley Park, UK — 23 July, 2004 -- ......AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved additional efficacy labelling information based on 12-week data for SEROQUEL (quetiapine), a psychotropic medication indicated for the treatment of acute manic episodes associated with bipolar I disorder. The data 1, part of the large scale effort to examine S...Serono receives FDA approval for Gonal-f RFF Pen to treat infertility
Geneva, Switzerland and Rockland, MA, May 27, 2004 -- Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that the United States Food and Drug Administration (FDA) has approved a prefilled device that delivers a new liquid formulation of the most prescribed gonadotropin in the world: Gonal-f RFF Pen (follitropin alfa injection).... ...Gonal-f RFF Pen is the first...FDA approves Enbrel to treat psoriasis
THOUSAND OAKS, Calif., and COLLEGEVILLE, Pa., April 30, 2004 Amgen (N), today announced that Enbrel® (etanercept) has been approved by the U.S. Food and Drug Ad ASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYEministration (FDA) for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy...Nutrition 21 seeks FDA approval of diabetes-related health claims
PURCHASE, NY, January 7, 2004 - Today, Nutrition 21, Inc. (Nasdaq: NXXI) announced that the Company filed a health claim petition with the U.S. Food and Drug Administration (FDA) requesting that the FDA allow use of eight dietary supplement health claims associating chromium picolinate supplementation with reduced risk of insulin resistance, type 2 diabetes and related disease conditions. Approx...Lexapro receives FDA approval for the treatment of generalized anxiety disorder
NEW YORK, December 18 - Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Lexapro (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI), for the treatment of generalized anxiety disorder (GAD), a condition that affects approximately four million Americans annually. The new indication is based on three studies, all...Drug company fees for FDA reviews havent accelerated approvals, study finds
ANN ARBOR, Mich. For the past ten years, drug companies have paid the U.S. Food and Drug Administration fees to review each new drug they want approved. But a new study shows that this program hasn't made the approval process any quicker -- its main goal -- than increased federal funding for the FDA was already doing before the industry fee program began. ......The study, by a team from the Uni...PRAECIS PHARMACEUTICALS INC receives FDA approval for Plenaxis
Waltham, MA --November 25, 2003 -- PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced that the United States Food and Drug Administration (FDA) has approved its lead product, Plenaxis (abarelix for injectable suspension). ... is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refus...FDA approves Climara Pro to treat menopause symptoms
Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Climara Pro®(estradiol/levonorgestrel) transdermal system. Climara Pro, a thin, translucent patch, is the first once-a-week, combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with meno...Pfizer's VFEND(R) receives FDA approval for treatment of esophageal candidiasis
NEW YORK, November 17, 2003 - Pfizer Inc said today that it has received U.S. Food and Drug Administration (FDA) approval to market VFEND (voriconazole), a broad spectrum antifungal medicine, for the treatment of esophageal candidiasis. ...... Candida organisms are normally found on skin and mucous membranes in healthy individuals, but in persons whose immune systems are weakened or compromised...FDA approves new approach to schizophrenia treatment
More than two million Americans suffer from schizophrenia, a brain disorder that impairs the ability to think clearly, relate to others and distinguish between reality and imagination. Missing daily medications is one of the most common problems in schizophrenia treatment and can often interfere with recovery. As many as 75 percent of patients with schizophrenia have difficulty taking their oral...FDA approves new HIV protease inhibitor, Lexiva (TM)
Research Triangle Park, N.C., Oct. 21, 2003 GlaxoSmithKline (GSK) today announced that the Food and Drug Administration has granted marketing clearance for Lexiva (fosamprenavir calcium) (Lex-ee'-va, formerly GW433908, or 908), a new protease inhibitor (PI) for the treatment of HIV infection in adults in combination with other antiretroviral medications. The following points should be considere...Shire receives approvable letter for adult ADDERALL XR(R) from FDA
Rockville, Maryland US October 20, 2003 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the US Food and Drug Administration (FDA) for ADDERALL XR (R) once daily treatment for adult Attention Deficit Hyperactivity Disorder (ADHD).... ...The Supplemental New Drug Application (sNDA), which was submitted to the FDA on...Society lauds FDA menopausal hormone therapy information campaign
Washington, D.C. -- The Society for Women's Health Research (SWHR) joins other health organizations today in praising the U.S. Food and Drug Administration's (FDA) menopause information campaign, designed to help women make informed decisions about using combination hormone therapy (estrogen and progestin) in the wake of uncertainty about such drugs....... "This is an important first step, but th...FDA approves Wellbutrin XL(TM)
Research Triangle Park, NC (August 28, 2003) -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Wellbutrin XL (bupropion hydrochloride extended-release tablets) for the treatment of major depressive disorder in patients 18 and older. The new once-daily medication will offer patients an effective and convenient option to treat their depression, with a low r...FDA-approved drugs shown to lower Alzheimer diseaserelated protein levels in mice
Alzhemier disease (AD) is characterized by the progressive accumulation of amyloid b protein (Abeta) in areas of the brain serving cognitive functions such as memory and language. In 2001, Todd Golde and colleagues demonstrated that three commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) were capable of selectively lowering the levels of Abeta42 (an isoform of the Abeta protein) in mice...FDA approves Baxters ADVATE for the treatment of hemophilia A
Deerfield, Ill., July 25, 2003 -- Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM for the prevention and control of bleeding episodes in people with hemophilia A. ADVATE is the first and only factor VIII made without any added human or animal plasma protei...FDA approves INSPRA, an aldosterone blocker for the treatment of hypertension
PEAPACK, N.J. (September 30, 2002) -- The U.S. Food and Drug Administration (FDA) granted marketing approval for Pharmacia's INSPRA ...Approximately 50 million, or one in four, adult Americans, have high blood pressure. Of those, 73 percent are not adequately controlled, and are at increased risk of heart attack, stroke, kidney failure, damage to the eyes, heart failure an...FDA approves Avapro for treatment of diabetic kidney disease in people with high blood pressure
(PRINCETON, NJ and PARIS, FRANCE, September 18, 2002) Bristol-Myers Squibb Company (NYSE:BMY) and Sanofi-Synthelabo, Inc. (NYSE:SNY and Paris Bourse: Sicovam code 12057) announced today that the U.S. Food and Drug Administration (FDA) has approved Avapro (R) (irbesartan) for a new indication: the treatment of diabetic nephropathy (kidney disease) in people who have hypertension and type 2 diabe...Former insider hits out at FDAs links with pharmaceutical industry
A former senior consultant with the Food and Drug Administration (FDA) has criticised the American regulator's close relationship with the pharmaceutical industry. Interviewed in this week's BMJ, he attacks the FDA's decision to allow the re-marketing of a controversial drug....... Dr Paul Stolley joined the FDA in July 2000 to look into the post-marketing safety of alosteron (Lotronex), a treat...