Navigation Links
Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits
Date:5/24/2010

lass="xn-location">Allston plant into compliance within given dates. If Genzyme fails to complete any step specified in the work plan, the company will have to pay a substantial fine. In addition, the consent decree provides a deadline for Genzyme to transfer its operations for filling drug vials from its Allston facility to other manufacturing sites or else it will have to disgorge further profits from the sales of drugs filled at Allston after that specific date.

FDA is working with Genzyme during the company's remediation to ensure availability of the company's medically necessary drugs.  

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
2. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
3. Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
4. Genzyme Corporation Selects Diplomat Specialty Pharmacy for 2008 Renagel Medicare Part D Assistance Program
5. Genzyme Announces Presentation of New Positive Data on Carticel(R)
6. Genzyme Genetics Announces Launch of Carrier Testing and Prenatal Diagnosis for Spinal Muscular Atrophy
7. Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
8. Genzyme and Isis Complete Licensing of Mipomersen
9. Genzyme and Isis Begin Second Phase 3 Trial Of Mipomersen
10. Pain Relief in Just One Visit with Genzymes Synvisc-One
11. Webcast Alert: Isis Pharmaceuticals and Genzyme Corporation to Present Mipomersen Phase 3 Data in HoFH During AHA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... SOMERSET, N.J. , May 4, 2015 ... 20 percent seek help. During May – National Hearing ... hearing loss could be missing out on the sounds ... through the trees. To ensure that you ... sounds that color our world, Oticon, Inc. offers practical ...
(Date:5/4/2015)... -- Impax Laboratories, Inc. (NASDAQ: IPXL ) announced that ...  Donna M. Hughes, as Senior Vice President, Human Resources ... President, Chief Compliance Officer. Both Ms. Hughes and Ms. ... Officer, Fred Wilkinson . "We are ... team," said Fred Wilkinson , President and Chief ...
(Date:5/4/2015)... Bayer HealthCare (Bayer) has entered into an ... ISIS ) on ISIS-FXI Rx, an antisense investigational ... Under the agreement Bayer will further develop and commercialize ... need. As part of the clinical development program, Bayer ... in an appropriate patient community. "Bayer ...
Breaking Medicine Technology:It's Better Hearing Month 2Impax Strengthens Leadership Team by Adding New Senior Vice Presidents for Human Resources and Compliance 2Impax Strengthens Leadership Team by Adding New Senior Vice Presidents for Human Resources and Compliance 3Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 2Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 3
... ... at ADA 2008, ... today announced data showing that the use of mealtime,SYMLIN(R) (pramlintide acetate) ... achieving diabetes treatment goals of,improved glucose control without weight gain or ...
... Alexza,Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today ... with AZ-002 (Staccato(R),alprazolam) in patients with panic disorder. ... which were the effect of AZ-002 on the ... of AZ-002 on the duration of a,doxapram-induced panic ...
Cached Medicine Technology:Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 2Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 3Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 4Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 5Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 2Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 3Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 4
(Date:5/4/2015)... TROY Healthcare Solutions is proud to be a ... (RUG) Conference in Baltimore, MD from May 11 – ... provides an opportunity for clients to gather to network, ... In addition to sponsoring the event, TROY Healthcare Solutions ... Conference. Attendees can stop by the TROY booth and ...
(Date:5/4/2015)... In May of 2010, after two years of constant ... wake of this tragedy, Ty’s parents Kirk and Laura Smalley ... grim reality of bullying and its devastating consequences. Stand for ... to share their story and offer education and tools that ... — a mission that took the Smalley family all the ...
(Date:5/4/2015)... DC (PRWEB) May 04, 2015 EY ... Kit Check as a finalist for the EY Entrepreneur ... Region. The awards program recognizes entrepreneurs who demonstrate ... financial performance and personal commitment to their businesses and ... by a panel of independent judges. Award winners ...
(Date:5/4/2015)... Ill., (PRWEB) May 04, 2015 New ... American Brain Tumor Association (ABTA) show that people diagnosed ... diagnosis and treatment options, including clinical trials, at the ... days to make difficult decisions about their course of ... launch of the first nationwide brain tumor volunteer network, ...
(Date:5/4/2015)... 2015 Dr. Benjamin Stong of Kalos ... the latest non-surgical double-chin eliminator. Dr. Stong is ... in Atlanta to offer Kybella treatments . The ... specifically under the chin, promising to safely dissolve fat ... patients who sought immediate solutions for their double chin ...
Breaking Medicine News(10 mins):Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 3Health News:WWE Legend "Rowdy" Roddy Piper Teams Up with Stand for the Silent for Timely Anti-Bullying Campaign 2Health News:WWE Legend "Rowdy" Roddy Piper Teams Up with Stand for the Silent for Timely Anti-Bullying Campaign 3Health News:EY announces Kit Check CEO and Co-founder Kevin MacDonald as an EY Entrepreneur Of The Year® 2015 Award finalist in the Greater Washington Region 2Health News:American Brain Tumor Association Poll Underscores Need for Greater Awareness and Education at Time of Diagnosis 2Health News:American Brain Tumor Association Poll Underscores Need for Greater Awareness and Education at Time of Diagnosis 3Health News:Facial Plastic Surgeon First in Atlanta To Offer Kybella Treatments To Reduce Chin Fat 2
... LAKEWOOD, Colo., Nov. 7 Mesa Laboratories,Inc. (Nasdaq: MLAB ... fiscal second quarter and six months ended September 30, 2007. ... 16% * Second quarter net income increases ... 39% For the second quarter of fiscal 2008, net ...
... cut their risk for neurodevelopmental trouble, researchers say, , , ... they couldn,t live without their morning coffee, but caffeine ... tiny premature infants. , New research finds that high ... early -- an average of 27 weeks gestation -- ...
... is ,Biomedical and Health Informatics, From,Foundations to ... 7 The American Medical,Informatics Association (AMIA) ... research and development in biomedical and health,informatics ... of hot topics,including privacy and security of ...
... Nov. 7 Isolagen(TM), Inc. (Amex:,ILE) announces the initiation ... for the treatment of moderate to severe,acne scars. Isolagen ... evaluate the Isolagen Therapy in treating nasolabial folds, or ... from acne which often scars, a,condition that can be ...
... drug program the largest of its kind, CLEVELAND, ... improving the health and wellness of its customers,supermarket retailer ... 8, 2007, the company will expand its popular $4 ... than 400. The program makes commonly prescribed dosages, ...
... But Zocor, a statin, still offers significant heart benefits, ... Lowering your cholesterol could interrupt your slumber. , A ... patterns in some users. , "The study suggests that ... said Dr. Sidney Smith, past president of the American ...
Cached Medicine News:Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 2Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 3Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 4Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 5Health News:Caffeine Therapy Boosts Preemies' Outcomes 2Health News:Caffeine Therapy Boosts Preemies' Outcomes 3Health News:AMIA's 31st Annual Symposium Opens in Chicago, IL 2Health News:AMIA's 31st Annual Symposium Opens in Chicago, IL 3Health News:Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars 2Health News:Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars 3Health News:Giant Eagle Expands Popular Generic Prescription Program and Now Offers '400 for $4' 2Health News:Cholesterol Drug Tied to Sleep Disturbances 2
Sonogage introduces a new generation of A-Scan biometers for visual axis measurements and IOL calculations. The Eye-Scan™ employs the latest electronic and transducer technologies for unsurpass...
Improve your refractive outcome, with AXIS II precision biometry A-scan. Biometry clinically proven as accurate as partial coherence interferometry while not limited by dense media....
... measurement modes (Phakic, Aphakic, and IOL mode), ... length measuring mode. Normal phakic mode measures ... conversion at 1550m/s. The new Phakic 2 ... sonic velocity for conversion: anterior chamber and ...
... Combination A-Scan/Pachymeter with graphic display ... A-scans and A-Scan/Pachymeter combination units include ... Dioptimum and Binkhorst II formulas. Audible ... you get to visual axis. Constant ...
Medicine Products: