The European Union (EU) has approved the European Commission's (EC) approval of a generic version of the erectile dysfunction medication sildenafil citrate, which is being developed as an alternative to the more expensive branded treatment Viagra.
The approval follows a major European Union health and safety programme, which includes one major health regulator - the EMEA.
The EU said it would consider the decision after a public consultation on 14 May.
"We are committed to ensuring the safety and appropriate use of sildenafil citrate in the EU," the European Medicines Agency said in a statement.
The EMEA said the drug was the first generic equivalent of Viagra approved by the European Commission since the drug was approved in 1998.
The drug, called sildenafil citrate, was the first approved to treat pulmonary arterial hypertension, a type of high blood pressure in the arteries of the lungs.
Sildenafil citrate, which has a longer half-life than the branded version Viagra, is still available as a generic drug.
The European Commission said the drug's market was valued at €13.3 billion in 2003, and sales were $8.7 billion, down from €11.5 billion in 2002 and $8.9 billion in 2001.
Sildenafil citrate, a phosphodiesterase type 5 inhibitor, has been linked to side effects including erectile dysfunction.
A study of the drug has also shown an increase in pulmonary artery pressure, the result of which has been confirmed by two separate large observational studies.
The drug's most common side-effect profile is a prolonged erection (priapism), and it can lead to heart attacks, strokes and a prolonged duration of sexual activity.
The Commission said sildenafil citrate's safety was the reason why it was approved, but it was not the reason why the market was worth its price.
The approval was announced after the results of a two-year study published in the journal,Pharmacoepidemiol Drug Saf, were presented at the American College of Cardiology annual meeting.
The study, which included 686 patients, evaluated sildenafil citrate's efficacy in patients with pulmonary arterial hypertension (PAH) and a high risk of sudden cardiac death.
Sildenafil citrate was associated with a modest but significant increase in the mean pulmonary blood pressure over the first month of treatment in the study, but the rate of decline was not significant.
The study was a randomized, placebo-controlled trial, which found that patients treated with sildenafil citrate had a significantly lower mean pulmonary blood pressure than patients treated with a placebo (p less than 0.05).
The study also showed that patients taking sildenafil citrate showed a reduction in adverse events compared to patients receiving placebo (8.5 versus 11.7%, respectively).
The study was financed by Pfizer Inc., which is the company that makes the generic version of the drug. Pfizer was not involved in the design of the study, but its authors and editors expressed their agreement with the conclusions of the study and with the results of the observational studies.
The European Commission has approved the EU's approval of sildenafil citrate, and it will monitor its use throughout the EU.
Sildenafil citrate is already available in the EU as an over-the-counter drug, the European Medicines Agency said.
The European Commission said it would consider the decision after a public consultation on 14 May.The commission said it expected sildenafil citrate to become a cheaper alternative to Viagra in the EU next year.
The European Commission said it was satisfied with the EU's approval of sildenafil citrate. It said that it was satisfied with the decision.The Commission said it was satisfied with the European Commission's approval of the drug and the positive findings of the observational studies.
The EU has said sildenafil citrate's safety has been the reason why it was approved, but it was not the reason why the market was worth its price.
The Commission said it would consider the decision after a public consultation on 14 May.
The European Commission said it was satisfied with the EU's approval of the drug and the positive findings of the observational studies.A generic version of the drug, sildenafil citrate, was approved for sale in the EU in 2003. It is already available in the EU as a generic.WASHINGTON (AP) — The prices of men’s health products rose sharply last year, raising the prospect of more competition for some of those pricey health products that cost hundreds of millions of dollars.
The increase in price increases is one of several new factors that could cause a sudden price spike that could drive up health care costs for some people, the Food and Drug Administration said Tuesday.
“The price increases will continue to be an issue for some consumers and it will continue to affect the prices of a large number of other health products,” Dr. Janet Woodcock, the agency’s acting director, said in a statement. “We will continue to monitor these prices closely and make any adjustments made to the prices of these products as soon as possible.”
The price increase comes on the heels of a new study in a that found that men’s health products made in the U. S. don’t increase as much as companies would have anticipated.
The study, which was done by the maker of consumer healthcare products, found that the price of products sold in the U. increased by 4.6 percent from July to December and that the increase was particularly pronounced for men’s health products such as erectile dysfunction pills. Analysts surveyed more than 40,000 men — or nearly 60 percent of the U. — for health information technology and computer science degrees.
The drug companies paid out more than $1.4 billion to settle lawsuits alleging that they illegally marketed and sold Viagra, the pill’s active ingredient, to physicians at inflated prices.
The increased prices are the result of a new study, the FDA said, by experts in the field.
“The current price increase is a significant blow to consumers, and this is likely to impact the overall health care system,” Dr. Woodcock said in a.
The study looked at more than 4,000 consumer healthcare products in the U. The analysis found that more than a third of those products are sold in the U. S., including health care products sold in foreign countries, and that the majority of the increased price increases are likely to occur in the U. S., where the drug companies have been trying to compete for customers in the past.
The FDA has yet to determine how many people in the U. are affected by the price increases. But the agency is working with industry experts and regulators to address the issue, including the makers of Viagra, to increase competition.
The FDA said that while it is working with industry to monitor the price increases, it is concerned that some of the new factors could cause a sudden price spike that could lead to more people being charged higher prices.
The price increases will continue to be an issue for some consumers, the FDA said.
“The price increases will continue to be an issue for some consumers,” Dr.
The price increases are the result of a new study in a that found that the price of products made in the U. don’t increase as much as companies would have anticipatedThe price increases are the result of a new study in a that found that the price of products sold in the U.
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