Navigation Links
BioMarin Announces FDA Approval for Kuvan
Date:12/13/2007

ent for patients suffering from HPA due to PKU or BH4 deficiency. If approved in the EU, it will receive 10 years of market exclusivity for this indication.

Important Safety Information

Prolonged exposure to elevated blood Phe levels in PKU patients can result in severe neurologic damage. The initiation of Kuvan therapy does not eliminate the need for careful monitoring of blood Phe levels and ongoing dietary management.

Some patients receiving Kuvan can experience significant drops in blood Phe levels. Patients should be monitored closely to ensure that blood Phe levels do not fall too low.

Not all patients with PKU respond to treatment with Kuvan. Response to treatment can only be determined by a therapeutic trial of Kuvan.

Kuvan has not been studied in patients with liver or renal impairment. Patients who have these conditions should be carefully monitored when receiving Kuvan. Caution should be used with the administration of Kuvan to patients who are receiving levodopa and drugs that affect nitric oxide-mediated vasorelaxation or folate metabolism.

The most serious adverse reactions reported during Kuvan administration (regardless of relationship to treatment) were gastritis, spinal cord injury, streptococcal infection, testicular carcinoma, and urinary tract infection. Mild to moderate neutropenia was also noted. The most common adverse reactions were headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting, and nausea.

To learn more about Kuvan and to access a copy of the full prescribing information, please visit http://www.Kuvan.com. Information on this website is not incorporated by reference into this press release.

About PKU

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase. PAH is requ
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
8. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
9. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
10. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
11. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/17/2014)... THOUSAND OAKS, Calif. , Oct. 17, 2014 /PRNewswire/ ... appointment of R. Sanders Williams , M.D., president ... L. Mahley Distinguished Professor.  "We are ... the Amgen Board," said Robert A. Bradway , ... deep and distinguished experience in academic medicine and his ...
(Date:10/17/2014)... , October 17, 2014 ... Markets ( http://www.researchandmarkets.com/research/rxznjk/micro_market ) has announced the ... : North American Automated External Defibrillators ... ,     (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ,The report North ... analyzes the market of devices based ...
(Date:10/17/2014)... 2014  UBM Medica US announces that Endocrinology ... other clinicians who treat patients with type 2 ... use of insulin .  Nearly all ... therapy – daily injections of one or more ... the function of pancreatic beta cells. Insulin is a ...
Breaking Medicine Technology:Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 2Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 3Micro Market Monitor : North American Automated External Defibrillators (AED) Market 2Endocrinology Network Features Special Coverage on Effective Use of Insulin 2Endocrinology Network Features Special Coverage on Effective Use of Insulin 3
... SUNNYVALE, Calif., Feb. 28, 2011 /PRNewswire/ ... company developing innovative technologies in diabetes management, announced that ... Silicon Valley Bank and ... used to help complete clinical trials and commercialize POGO™, ...
... Feb. 28, 2011 Advanced Cell Diagnostics, Inc. ... study utilizing RNAscope™ technology to detect human papillomavirus ... head and neck cancer. HPV status determined by ... patient outcome and highly concordant with that determined ...
Cached Medicine Technology:Intuity Medical Secures $20M Credit Facility From Silicon Valley Bank and Oxford Finance Corporation 2Intuity Medical Secures $20M Credit Facility From Silicon Valley Bank and Oxford Finance Corporation 3ACD Announces Clinical Study Results Using its RNAscope™ Technology 2ACD Announces Clinical Study Results Using its RNAscope™ Technology 3
(Date:10/20/2014)... (PRWEB) October 20, 2014 AttorneyOne.com, a recognized ... latest information from the FDA on Sit and Slim ... 10 not to purchase or use Sit and Slim II ... Slim II is promoted as weight loss product on various ... from the market in 2010 for safety reasons, can significantly ...
(Date:10/20/2014)... October 20, 2014 Based on ... the only imaging assays capable of determining DNA ... test.  With these three dimensions of high-resolution data, ... detect the widest range of disease-causing genetic rearrangements, ... by other genomic tools, including today’s advanced sequencing ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 It’s hard to ... many orphans and vulnerable children around the world, it’s a ... some people, many children are forced to walk barefoot on ... their families or play with their friends. , Buckner ... with Air1 Radio in October to encourage support ...
(Date:10/19/2014)... Hastings and Hastings, a Phoenix personal injury law ... greater Phoenix area and across Arizona reports record demand ... automobile accidents. Statistics have indicated a steady increase in ... such, Hastings and Hastings has seen a steady increase ... have been injured through no fault of their own ...
(Date:10/19/2014)... Dallas, Texas (PRWEB) October 20, 2014 ... therapeutic development for Partial Seizure, complete with comparative ... target, mechanism of action (MoA), route of administration ... and featured news and press releases. It also ... for Partial Seizure and special features on late-stage ...
Breaking Medicine News(10 mins):Health News:FDA Advises Not to Use Sit and Slim II: AttorneyOne Monitors and Keeps Consumers Informed 2Health News:KromaTiD Launches Genome Screening and Discovery Services 2Health News:KromaTiD Launches Genome Screening and Discovery Services 3Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 3Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 4
... , ST. LOUIS, Aug. 24 ... herbicide Atrazine have attorney and clean water advocate Steve Tillery ... and accountability for the herbicide,s manufacturers. , , ... the New York Times and the Peoria Journal Star have ...
... , , , OAKLAND, ... LATINA Style magazine on the publication,s list of the 50 ... , The LATINA Style survey, now in ... the value of diversity in the workplace, and identifies the corporations in ...
... Institute of Allergy and Infectious Diseases (NIAID), a component ... applications for a new initiative to establish a consortium ... these cooperative centerswhich together will receive funding up to ... immune system under normal conditions and to understand how ...
... - Concussions, whether from an accident, sporting event, or ... mental processes. Scientists have debated for centuries whether concussions ... changes that merely impair the way brain cells function, ... at Albert Einstein College of Medicine of Yeshiva University ...
... State University study shows that invigorated and dedicated employees ... home life. K-State psychology researchers studied how positive ... interactions. They found that employees who are engaged in ... dedication and absorption in daily activities, have better moods ...
... , SWARTZ CREEK, Mich., Aug. ... Health Services Division is partnering with CareSource in Ohio to ... outcomes and reduce healthcare costs associated with the disease. As ... is focused on the early identification and treatment of their ...
Cached Medicine News:Health News:Korein Tillery: Is Time Running Out for the Manufacturers of the Herbicide Atrazine? 2Health News:Korein Tillery: Is Time Running Out for the Manufacturers of the Herbicide Atrazine? 3Health News:Kaiser Permanente Named 2009 Company of the Year by LATINA Style Magazine 2Health News:Kaiser Permanente Named 2009 Company of the Year by LATINA Style Magazine 3Health News:NIAID to fund new human immune profiling research centers 2Health News:Strong link found between concussions and brain tissue injury 2Health News:Strong link found between concussions and brain tissue injury 3Health News:Researchers find that employees who are engaged in their work have happier home life 2Health News:Diplomat Specialty Pharmacy Partners With CareSource -- Launches Chronic Kidney Disease Management Program with Ohio Plan 2
... -4C. 5.5 Cubic Ft. ... light. Manual push button ... Two shelves. In-door shelves ... thermostat. Magnetic gasket. Hermetically ...
Designed to meet the requirements of reagent grade water for routine analysis....
... Needs, Synergy systems produce ultrapure water from pre-treated ... 1.2 L/min to meet the basic needs of ... dual-wavelength UV lamp (185 nm and 254 nm) ... contaminants (< 5 ppb TOC when fed by ...
... mechanism for speed, stability and durability. ... display modes, multiple units of measure, ... auto print, and GLP/GMP/ISO output including ... clock. Touch-key calibration with external weights ...
Medicine Products: