Showing posts with label Medication. Show all posts
Showing posts with label Medication. Show all posts

Monday, April 11, 2011

Seniors Group Asks Medicare Part-D Plans To Provide Affordable Gout Medication For Patients


Main Category: Medicare / Medicaid / SCHIP
Also Included In: Gout
Article Date: 25 Feb 2011 - 2:00 PST window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }()); email icon email to a friend   printer icon printer friendly   write icon opinions
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As part of the 60 Plus Association's "Keeping Seniors Safe" project, the organization's chairman, Jim Martin, recently sent letters to the CEOs of five Part-D Medicare plans, urging them to provide accessible colchicine-based medications to gout patients after untested and potentially harmful options were removed from the marketplace as part of an important Food and Drug Administration (FDA) safety-initiative.

"In light of the FDA's removal of unapproved colchicine from the market, [these outlying companies] must follow the lead of other Part-D insurers around the country and reclassify COLCRYS as a tier-1 or 2 drug to ensure seniors have access to their vital gout medications" Martin wrote to the CEOs of the companies. "It is unjust to force patients to suffer through often excruciatingly-painful acute gout flare-ups despite the fact that they were promised affordable coverage for their medications."

The FDA's "Unapproved Drugs Initiative" calls for the removal of unapproved drugs from the market when approved versions exist. The agency recently acted on this initiative by removing untested colchicine products from the market.

"The FDA did what was best for patients by removing untested colchicine products from the market," wrote Martin. "We hope your company will also act in the best interest of patients and immediately work to ensure that seniors enrolled in your Part-D plan have access to the colchicine products they were promised-and sorely need."

In addition to the CEOs of offending insurance companies, copies of Martin's letter were sent to Secretary of Health and Human Services Kathleen Sebelius, HHS Deputy Secretary William Corr, CMS Administrator Donald Berwick, Senator Bill Nelson (D-FL), Representative Pete Stark (D-CA), Representative Nancy Pelosi (D-CA), Representative Henry Waxman (D-CA), Senator Chuck Schumer (D-NY), Senator Sherrod Brown (D-OH), Senator Robert Menendez (D-NJ), Senator John Cornyn (R-TX), and Representative Allyson Schwartz (D-NY).

Source:
60 Plus Association

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posted by Gregg on 25 Feb 2011 at 9:36 am

Where the article is mistaken is in saying that the former versions of Colchicine were "potentially harmful". There is nothing different chemically about Colcrys, it merely has different labeling. For the privilege of getting this new "special" label on the package, the FDA says you must pay one-hundred and fifty dollars (or more) a month, instead of the previous twenty dollars or so.

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Sunday, April 10, 2011

Merck Announces FDA Acceptance Of New Drug Application For Investigational Ophthalmic Medication SAFLUTAN(R) (Tafluprost)


Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Mar 2011 - 0:00 PST window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }()); email icon email to a friend   printer icon printer friendly   write icon opinions
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Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the New Drug Application (NDA) for SAFLUTAN® (tafluprost), Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). SAFLUTAN is the proposed trade name for tafluprost in the United States.

Merck submitted an NDA to support the proposed use of SAFLUTAN for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. SAFLUTAN is believed to help increase the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor). SAFLUTAN is currently approved in several European countries, including the United Kingdom, Spain and Italy. Additional launches in other countries are expected, pending regulatory approvals.

"Merck has been providing new therapies to help treat eye diseases for more than 50 years," said Joseph Markoff, Ph.D., M.D., global director, Scientific Affairs, Ophthalmology, Merck. "The acceptance of the NDA submission for tafluprost is an important milestone in our effort to bring forward an additional therapeutic option for patients with primary open-angle glaucoma or ocular hypertension."

On April 15, 2009, Merck and Santen Pharmaceutical Co., Ltd. entered into a worldwide licensing agreement for tafluprost. Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Santen retains commercial rights to tafluprost in most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan. Santen will have the option to co-promote SAFLUTAN in the United States, if approved.

Source:
Merck

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Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

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For any corrections of factual information, or to contact the editors please use our feedback form.

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View the original article here