Medical blog » Approves

FDA Approves New Cholesterol Drug Vytorin

admin — Sat, 03 Jan 2009 14:34:55 +0000

January 12, 2009 7:31 a.m. EST
Miami, FL (AHN) – Federal regulators approved the use of a controversial drug to treat high cholesterol last week.
The Food and Drug Administration gave Vytorin the OK a year after a study came out suggesting it wasn’t any more effective than Zocor in lowering bad cholesterol.
Vytorin is a combination of simvastatin, the generic name for Zocor, and ezetimibe.
But now the FDA said a recent trial found a 56-percent reduction in bad, or LDL, cholesterol levels in patients taking Vytorin compared with a 39-percent decrease in those taking Zocor.
The FDA said carotid artery thickness in patients taking Vytorin for two years was higher than those taking Zocor, but that the difference was not “statistically significant.”
Both Vytorin and Zocor are manufactured by Merck, but Zocor is also available in generic form after the company lost patent protection in 2006.

FDA Approves First Gout Drug For 40 Years

admin — Wed, 24 Dec 2008 16:16:06 +0000

The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with
gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda
Pharmaceuticals North America is the sole developer and marketer of the product in the US.
According to a statement from Takeda, febuxostat is a new highly potent non-purine selective inhibitor of xanthine oxidase, and has a completely
different structure from the currently used xanthine oxidase inhibitor, which was developed over 40 years ago. Xanthine oxidase is an enzyme
involved in the production of uric acid.
Febuxostat lowers the concentration of uric acid in the blood of hyperuricemic patients with gout. The drug has been proved to be safe and effective
in clinical trials, and the dose does not need to be adjusted for patients with mild-to-moderate renal or hepatic impairment (kidney or liver
problems).
ULORIC will be available as 40 mg or 80 mg tablets to be taken once a day. It is not recommended for asymptomatic hyperuricemia, said the
company’s press release.
Febuxostat was discovered by another Japanese company, Teijin Pharma. Their president Osamu Nishikawa said in a press statement released jointly
with Takeda that:
“This FDA approval granted to Takeda Pharmaceuticals North America, along with the EMEA (European Medicines Agency) approval given last year
to Ipsen, our licensee for febuxostat in Europe, marks a significant milestone for our global business.”
He said Teijin would be developing febuxostat themselves for the Asian market, as well as collaborating with other pharma companies. The company
wishes to strengthen its global operations by “expanding areas where febuxostat is available and increase the presence of the product to be widely used
by patients worldwide,” he added.
President of the Takeda parent company in Japan, Yasuchika Hasegawa, said:
“The approval of ULORIC offers patients and healthcare providers in the US for the first time in 40 years, a novel treatment option for patients who
have hyperuricemia with gout, where there are still unmet clinical needs.”
Gout is a common, painful form of arthritis that causes swollen, red, hot and stiff joints. It occurs when uric acid builds up in the blood,
because the body produces too much or can’t get rid of it (some medications can slow down elimination), or from eating too many foods rich in
purines, such as liver and dried beans.
Pseudogout is sometimes confused with gout because the symptoms are similar; however, it is caused by calcium phosphate, not uric acid.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), there could be as many as 6 million Americans aged
20 and older who have had gout at some time in their lives. It is more common in men aged 40 to 50, and women rarely develop it before the
menopause. Also people who have had an organ transplant are more susceptible.
NIAMS suggest people may be at risk of developing hyperuricemia and gout if they are on certain medications, these include:
Diuretics, such as furosemide (Lasix1), hydrochlorothiazide (Esidrix, Hydro-chlor), and metolazone (Diulo, Zaroxolyn).
Drugs containing salicylate, such as aspirin.
Niacin, a vitamin also known as nicotinic acid.
Cyclosporine (Sandimmune, Neoral), a medication used to suppress the immune system.
Levodopa (Larodopa), a drug used in the treatment of Parkinson’s disease..
Takeda Pharmaceuticals North America, Inc, whose head office is in Deerfield, Illinois, is a wholly owned subsidiary of Takeda Pharmaceutical
Company Limited whose head office is in Chuo-ku, Osaka, Japan.
Sources: Takeda Pharmaceutical Company Limited press release, NIAMS.
Written by: Catharine Paddock, PhD
For any corrections of factual information, or to contact the editors please use our
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FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of …

admin — Wed, 24 Dec 2008 12:19:58 +0000

These gains don’t cause pain. A capital gain is the amount of money you pocket by selling one of your investments for more
than you paid for it. Technically, capital gains only count for what’s called a capital asset, but that’s really just anything
you own for investment purposes. Stocks and bonds obviously qualify, but your house and household furnishings can also count.
For
tax purposes, capital gains are classified as either long-term (held for more than one year) or short-term (held for less
than one year) and there are different tax implications for how long you hold onto a capital asset. For most long-term capital
gains, you’re taxed no more than 15% of the value of the asset. Short-term gains get taxed as regular income, so you pay the
rate for the tax bracket you’re in.
Capital gains can also be realized or unrealized. When you physically sell an asset
like a stock, you’ve realized the capital gain. When you’re holding the stock, and it has a value over its purchase price,
but you’re not selling it, you’ve got an unrealized gain, and you won’t realize it until you sell.
In a perfect world,
we’d all have capital gains. But no one¿s that smart or lucky. When the value of an asset at sale is below what you’ve paid
for it, it’s called a capital loss. The good news is that the government lets you count that loss against any gains you’ve
had, lowering the taxes you pay. In fact, many people who sell a stock that has risen far over their purchase price tend to
sell some stinkers, too, at the same time for the tax benefit. This is known as a capital-loss offset.

FDA Approves New Gout Medicine

admin — Wed, 17 Dec 2008 19:51:49 +0000

For the first time in more than forty years there’s a new medication receiving FDA approval for the treatment of gout.
That often affects one joint, which is most often the big toe, but can happen with many joints in the body.
It’s the most common inflammatory arthritis is men over age 40.
The medicine is called Uloric.
It’s a once daily oral medication that works by blocking an enzyme which helps prevent uric acid production, lowering uric acid levels.
Check out the related link for more information.

FDA approves BioImagene device Silicon Valley / San Jose Business …

admin — Sun, 14 Dec 2008 02:15:20 +0000

said Wednesday it received clearance from the Food and Drug Administration for its Pathiam System with iScan for assessment of HER2/neu immunohistochemistry tests.
Cupertino-based BioImagene said the scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients in order to determine if they are candidates for treatment with the breast cancer drug Herceptin.
“This FDA clearance is a significant accomplishment for BioImagene and validates the innovations in our digital pathology hardware and software,” said CEO Dr. Ajit Singhe. “Many pathology workflow innovations are possible only by going digital. This clearance will help increase adoption of digital pathology and accelerate the progress toward personalized medicine.”

FDA Approves RiaSTAP for Treatment of Bleeding in Patients with …

admin — Thu, 04 Dec 2008 06:36:40 +0000

Washington, D.C. – infoZine – The U.S. Food and Drug Administration licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding.
People with congenital fibrinogen deficiency are unable to make sufficient amounts of fibrinogen, which plays an important role in blood coagulation by helping to form blood clots and prevent bleeding. Fibrinogen is manufactured in the liver and circulates in the blood plasma in a normal concentration of 250-400 mg/dL.
“This product offers much-needed treatment for the small number of patients with congenital fibrinogen deficiency,” said Jesse Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “If bleeding occurs in the brain or other organs and is left untreated, it may lead to blood loss, organ damage and death.”
Fibrinogen deficiency affects only 150 to 300 people in the United States and is usually diagnosed at birth when newborns bleed from their umbilical cord site. Children with the defect need to curtail activities because of risk of bleeding from minor trauma.
RiaSTAP is an intravenous fibrinogen concentrate made from the plasma of healthy human blood donors. The product is indicated for patients who have no fibrinogen or low levels of the substance, an abnormality known as afibrinogenemia, or for those patients whose fibrinogen levels are below 50 mg/dL, an abnormality known as hypofibrinogememia. The product is not indicated for patients with dysfibrinogenemia, who may have normal fibrinogen levels but defective fibrinogen function. Patients such as these are at risk for both bleeding and clotting complications.
The licensing of RiaSTAP was supported by a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 mg/kg of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness, a surrogate marker likely to predict clinical benefit. Fever and headache were the most common adverse reactions.
Clinical benefit will be further verified in a postmarketing study which will include both afibrinogenemic and hypofibrinogenemic patients.
Orphan drugs are drugs or biologics intended for use in a rare disease or condition. Manufacturers are qualified to receive certain government benefits in exchange for developing such products. RiaSTAP [Fibrinogen Concentrate (Human)] was developed under the FDA’s accelerated approval regulations.
The drug is manufactured by CSL Behring, Marburg, Germany.

FDA approves shortened anthrax-vaccine course

admin — Wed, 03 Dec 2008 02:00:49 +0000

Dec 22, 2008 (CIDRAP News) – The US Food and Drug Administration (FDA) recently approved a new version of BioThrax—the nation’s only licensed anthrax vaccine—that requires fewer doses and changes the injection route.
Emergent BioSolutions, maker of BioThrax, said in a Dec 19 press release that the FDA’s approval of the company’s supplemental biologics license application for its anthrax vaccine adsorbed (AVA) allows a new schedule for the vaccine: five intramuscular (IM) doses compared with the previous regimen of six subcutaneous doses.
The vaccine is required for US military members who are deployed to the Middle East, but some have objected to the vaccine because of side effects.
The FDA’s approval is based on early findings from a large multicenter trial that was initiated by the US Centers for Disease Control and Prevention (CDC) in 2002, according to the statement from Emergent. The goal of the study is to evaluate if as few as three doses of the vaccine administered over 6 months with booster doses up to 3 years apart will offer sufficient protection.
In October, researchers published their interim findings on the new BioThrax schedule in the
. Investigators reported that the subjects who received three or four IM, doses over 6 months had similar antibody responses to those who received four subcutaneous doses over 6 months. The volunteers who received four IM doses had fewer injection-site reactions than those who received four subcutaneous doses.
The report said the subcutaneous injection route might make the vaccine more tolerable and that reducing the number of doses in the AVA schedule could help conserve the vaccine supply.
According to the new schedule, the vaccine is administered at 0, 1, 6, 12, and 18 months. The previous course involved the same schedule, plus a dose at 2 weeks. The company recommends annual booster doses with the new dosing, the same as for the previous schedule.
Daniel Abdun-Nabi, Emergent’s chief operating officer and president, said in the statement that the FDA’s approval is an important milestone in the company’s mission to advance the usefulness of BioThrax. “We are pleased that the US government shares our commitment to enhancing this critical countermeasure. The CDC is to be applauded for their hard work and diligence throughout this important effort,” he said.
After the CDC completes more analysis of the study data in 2009, the company may seek FDA clearance to further shorten the vaccine course, if the strategy is supported by the data, Emergent said in its press release.
Since 1998, federal officials have ordered 32 million doses of BioThrax, and nearly 7.9 million doses have been administered to more than 2 million military members, the company said.

FDA approves first eyelash-lengthening drug

admin — Sat, 22 Nov 2008 21:47:45 +0000

BEIJING, Dec. 29 (Xinhuanet) — The Food and Drug
Administration (FDA) recently approved the first drug that will help with
producing longer eyelashes, according to media reports Monday.
Latisse, produced by the company of Allergan, is
supposed to treat those who have hypotrichosis, a condition in which a person
does not have enough eyelashes. It will be available by prescription starting in
the first quarter of 2009.
The active ingredient in the once-daily prescription
treatment is bimatroprost, the same ingredient that is in Allergan’s glaucoma
treatment Lumigan.
Allergan states that “Latisse users can expect to
experience longer, fuller, and darker eyelashes in as little as eight weeks,
with full results in 16 weeks.” If Latisse is stopped, eyelashes will gradually
return to their previous appearance as new eyelashes grow in.
The company also stated, “Latisse is the first and
only science-based treatment approved by the FDA to enhance eyelash prominence
as measured by increases in length, thickness and darkness of eyelashes.”
Allergan noted that Latisse may cause darkening of
the eyelid skin, which may be reversible, and it “may also cause increased brown
pigmentation of the colored part of the eye, which is likely to be permanent.”
The drug is the first prescription product for
lengthening eyelashes, making sales forecasting a little difficult although
Allergan said it estimates global peak sales could top 500 million U.S.
dollarsa year.

FDA Approves 18 Drugs from Pharma Company Accused of Conspiracy, Fraud

admin — Thu, 20 Nov 2008 15:42:43 +0000

(NaturalNews) The FDA has approved 18 products for market from generic drug manufacturer Ranbaxy Laboratories, even though the company is currently being investigated by Congress for making substandard products and conspiring to fraudulently cover it up.
“Allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information,” the Department of Justice said.
The Department of Justice is investigating claims that Ranbaxy, India’s largest drug manufacturer, produced HIV medication that contained insufficient active ingredients or was adulterated with other ingredients. These drugs were then used to treat patients in Africa.
Other drugs are also suspected of containing active ingredients in concentrations that are either too low or too high. The company also stands accused of attempting to conceal manufacturing procedures that do not meet FDA standards and of forging documents relating to U.S. government investigations of its practices.
Finally, Ranbaxy is being investigated for falsifying data suggest that its generic drugs are absorbed into the body in a similar fashion to brand-name products. This proof is an essential part of the process of gaining FDA approval for a generic drug without going through large clinical trials.
In July, Congress also began a probe into why
had not taken action against Ranbaxy, even though it had known for months of allegations against the company. As part of this probe, the FDA was asked to provide information on every FDA-approved Ranbaxy product and the approval process that it went through.
Former FDA Deputy Commissioner Mary Pendergast has criticized the FDA’s failure to take action against Ranbaxy and its products.
Because the FDA “wouldn’t be confident of the accuracy and reliability of the information in the applications,” Pendergast said, “they might be approving a product that ought not be approved.”
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FDA Approves 1st Drug from Genetically-Engineered Animal

admin — Fri, 14 Nov 2008 05:01:35 +0000

For the first time in history, a drug produced from a genetically-engineered animal has won the approval of the Food and Drug Administration. The FDA on Friday gave its approval to the use of genetically-altered goats to produce a blood-clot preventing drug called antithrombin. The anti-clotting agent is manufactured by a herd of some 200 bioengineered goats on a carefully controlled farm in Massachusetts. The move by the FDA has had its fair share of critics, with the Humane Society of the United States among the most vocal. The group has expressed concern about what it calls, “a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures.” Read more at
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