Navigation Links
FDA Panel to Consider Over-the-Counter Statin
Date:12/13/2007

Experts oppose idea on medical and safety grounds

THURSDAY, Dec. 13 (HealthDay News) -- For the third time in seven years, a U.S. Food and Drug Administration advisory panel has been asked to recommend making Merck & Co.'s statin drug Mevacor available over the counter.

But with groups such as the American Medical Association, Public Citizen and Consumers Union lined up against it, experts think Merck's proposal is likely to be rejected once again when the panel meets on Thursday.

"The third time is not the charm," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "It's time to move on."

Merck's proposal is being presented to a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. The FDA does not have to follow the advice of its advisory panels, but it usually does.

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck stated. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

However, in 2000 and in 2005, the FDA rejected similar proposals because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor the people taking statins.

M
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4 5

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel to Consider Over-the-Counter Statin
(Date:12/26/2014)... WA (PRWEB) December 26, 2014 “Many ... deal with personal injury claim issues and phone calls ... recently released an article featuring their free eBook ... exceptionally helpful eBook on pedestrian and bicycle auto accident ... attorney is fully capable of professionally handling their case ...
(Date:12/25/2014)... The microscopy market is estimated ... reach $5,756.0 million by 2019. Optical microscopy is ... electron microscopes product segment is expected to show ... Rising focus on nanotechnology, technological advancements, and increasing ... market. , Get Full Copy of Report @ ...
(Date:12/25/2014)... York, New York (PRWEB) December 25, 2014 ... the 2010 DePuy ASR hip recall ( http://www.consumerinjurylawyers.com/DePuy/ ) ... LLP reports. According to an Order issued in the ... 20th, the Court will convene an open conference on ... Building and United States Courthouse in West Palm Beach, ...
(Date:12/25/2014)... Recently, BellasDress has launched ... wedding dresses. BellasDress has chosen their best-selling lace wedding ... for the holiday season. , Now, BellasDress.com features ... gowns here at discount prices. The business hopes everyone ... website. , “All our elegant products are ...
(Date:12/25/2014)... By Dennis Thompson ... -- Very sick children with complex chronic illnesses can receive ... a "medical home," with easy access to a team of ... were less likely to become seriously ill and need either ... received treatment at an enhanced medical home clinic at the ...
Breaking Medicine News(10 mins):Health News:Guide to Handling Pedestrian and Bicycle Accidents Released By The Jones Firm, Featured in Recent Article 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 3Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 4Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 3
... In a study to be presented today at ... Pregnancy Meeting , in Chicago, researchers will unveil findings ... adrenal gland is a better predictor of pre-term birth ... of Maryland and Yale University have followed up on ...
... Ill. (February 4, 2010) In a study to be ... meeting, The Pregnancy Meeting , in Chicago, researchers will unveil ... for depression during pregnancy. "Depression during pregnancy is an ... the mother and the baby as well as the rest ...
... , , TORRANCE, Calif. , Feb. ... insurance brokerage and consulting firm in California , has ... best-in-class services.  An example of that commitment to quality and ... division. , TelaDoc is a national network of board-certified physicians ...
... LOUIS , Feb. 3 Young Innovations, Inc. (Nasdaq: YDNT ... 31, 2009 . , Sales for the fourth quarter of 2009 were ... from the $23.9 million reported in the fourth quarter of 2008. ... quarter of 2008 to $5.5 million in the fourth quarter of ...
... February 3, 2010 Recent immigrants to Ontario have ... term residents, according to preliminary study results from researchers at ... (ICES). "What we learned could translate into long-term health ... neurologist at St. Michael,s Hospital. "We need to do further ...
... on Wii boards, report notes , WEDNESDAY, Feb. 3 (HealthDay ... in 2006, more than just the ligaments and tendons in ... new report details foot injuries that have been incurred while ... games were introduced, patients typically presented with ligament injuries of ...
Cached Medicine News:Health News:Ultrasound measurement of fetal adrenal gland a better predictor of preterm birth 2Health News:Acupuncture found effective against depression during pregnancy 2Health News:Keenan Partners With TelaDoc for 24/7 Phone Access to Physician Network 2Health News:Keenan Partners With TelaDoc for 24/7 Phone Access to Physician Network 3Health News:Young Innovations, Inc. Announces Record EPS for the Year 2Health News:Young Innovations, Inc. Announces Record EPS for the Year 3Health News:Young Innovations, Inc. Announces Record EPS for the Year 4Health News:Young Innovations, Inc. Announces Record EPS for the Year 5Health News:Young Innovations, Inc. Announces Record EPS for the Year 6Health News:Young Innovations, Inc. Announces Record EPS for the Year 7Health News:Risk of stroke lower for recent Ontario immigrants: study 2Health News:Wii Popularity Leads to New Kind of Gaming Injury 2Health News:Wii Popularity Leads to New Kind of Gaming Injury 3
(Date:12/24/2014)... 2014  Actavis plc (NYSE: ACT ... a complete response letter from the U.S. Food ... Application (NDA) for the fixed-dose combination (FDC) of ... Photo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO ... receipt of a complete response letter, Actavis remains ...
(Date:12/24/2014)... Dec. 24, 2014 Soligenix, Inc. (OTCQB: ... company developing products that address unmet medical needs ... announced today that on December 24, 2014 it ... The Company raised approximately $2.3 million in ... use the net proceeds from the offering to ...
(Date:12/24/2014)... and FARMINGTON, Conn. , Dec. ... MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific ... significant unmet medical need and commercial potential, today ... placement of 2,050,000 shares of its common stock ... of its common stock.  Funds under the management ...
Breaking Medicine Technology:Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 2Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 3Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 4Soligenix Announces Closing of Public Offering of Units 2Soligenix Announces Closing of Public Offering of Units 3Palatin Completes $20 Million Equity and $10 Million Debt Financings 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 3Palatin Completes $20 Million Equity and $10 Million Debt Financings 4
... WATERTOWN, Mass., Oct. 17 EnVivo ... developing drugs for,neurodegenerative diseases, today announced ... Alzheimer,s, Schizophrenia and Huntington,s,diseases. EnVivo ... orally,active Alpha 7 Nicotinic Acetylcholine Receptor ...
... ... flow, muscle oxygen supply, HOBOKEN, N.J., Oct. 17 A ... Pycnogenol(R),(pic-noj-en-all), an antioxidant plant extract from the bark of the French,maritime ... leads to an increase in blood flow and oxygen supply,to muscles. ...
Cached Medicine Technology:EnVivo Pharmaceuticals Announces Progress on Major Drug Programs Focusing on Alzheimer's, Schizophrenia and Huntington's Diseases 2New Study: Pine Bark Extract Boosts Nitric Oxide (NO) Production 2New Study: Pine Bark Extract Boosts Nitric Oxide (NO) Production 3
Clinac Platinum Plus accelerators offer all the high performance features of the EX series and come with the latest high-precision dose sculpting technology for advanced tumor control....
... EX accelerators are true ... Varian multileaf collimation and ... which enable you to ... computer-driven IMRT treatments, as ...
The Clinac 2300 C/D family of accelerators are reliable, easy-to-use, flexible and cost-effective systems....
... reliable system. Varian accelerators offers highest ... fastest beam-on times to full stability ... milliseconds, pulse-to-pulse beam control for dynamic ... of multileaf collimator (MLC) products that ...
Medicine Products: