NEW YORK -- New York City's city council recently voted to pass an initiative to eliminate barriers to obtaining erectile dysfunction medications, which are commonly referred to as "Viagra" or "the little blue pill." But before the vote, city officials will need to decide whether it's legal to do so. A proposed bill would require a "new form of approval" before drug manufacturers can import prescription drugs, including Viagra. So far, there is no "new form of approval" to the proposal.
The City Council voted on the bill on Monday, but only with a "new form of approval." The proposal would require a city-wide "informed consent" process in which drug makers can show that they are fully aware of the drug's potential risks and benefits, such as "impotence" and "trouble getting an erection," among other conditions. The proposal would also require a "new form of approval" from the drug manufacturers before the drug can be dispensed. That process would take more than five years.
The proposal, which is currently awaiting approval from the Food and Drug Administration, is the first of its kind in New York's "New York City" drug supply chain. Viagra, for example, costs about $100 for a month's supply, while Cialis costs $30 for a month's supply, according to a company website. Cialis was originally developed for treating impotence, but is now available in the United States and elsewhere for other conditions, such as erectile dysfunction and benign prostatic hyperplasia.
The drug industry, which includes pharmaceutical companies, is fighting to keep Viagra in the market. And it's a war between Pfizer and Eli Lilly andounter the potential for counterfeit drugs. Last week, Eli Lilly's patent on Viagra expired in the United States, paving the way for its generic competitor, GlaxoSmithKline. A Pfizer spokeswoman explained that the expiration of a patent could result in a generic version of the drug facing generic competition in the United States. But the company still retains the exclusive right to market the drug to U. S. consumers.
"We're fighting to keep Viagra," said Michael J. Wolfe, director of public policy for the pharmaceutical industry. "We need to keep it in the marketplace." Wolfe warned that the pharmaceutical industry, "is the largest consumer group in the nation" for drugs that treat erectile dysfunction. He also said it's the industry's best weapon to help keep people healthy.
Last week, a proposal to allow pharmacists to order Viagra without a doctor's prescription was rejected by City Council, which has already voted on the proposal.
"I have the impression that if the city would just give a public hearing on this, it would be one more vote," said Michael J. "I think there's a lot of anger on the part of the city council." Wolfe, who has called for a new form of approval, said the drug industry has been trying to get Pfizer to do something about the problem.
"If it were me, I'd say, 'I can't do anything about it,'" Wolfe said. "So I think the way the city is going about it is a little bit of a stretch, but I think it's going to be a lot easier."
Viagra, a widely used erectile dysfunction medication, was developed by Pfizer Inc. and approved by the FDA in 1998 for treating erectile dysfunction in men. It was first marketed as a pill and is now available to millions of men worldwide. Pfizer, which owns the patent on Viagra, filed a patent with the U. Food and Drug Administration in December 2002, which allowed generic makers to market a different version of the drug. Viagra is sold in several countries around the world, including New Zealand and the United States.
Viagra is used to treat erectile dysfunction in men by helping to relax blood vessels and increasing blood flow to the penis.
The Food and Drug Administration has granted a tentative approval for Cialis, the first drug designed to address erectile dysfunction and improve sexual performance in men who are using nitrates, or nitric oxide donors, to treat conditions such as heart failure, angina, and some forms of high blood pressure.
The drug, which was developed by Pfizer, was developed to address erectile dysfunction and improve sexual performance in men who are using nitrates, or nitric oxide donors, to treat conditions such as heart failure, angina, and some forms of high blood pressure.
However, Cialis did not have the same level of efficacy as the older drug Viagra, which was developed to treat erectile dysfunction.
Cialis, which is currently the first approved drug for treating erectile dysfunction, was developed by Pfizer to address erectile dysfunction in men with coronary artery disease. The drug was developed as a treatment for cardiovascular disease, and the company also noted the company's decision not to pursue further clinical trials for the drug in order to expand its sales in the United States and to provide the company with more options for patients to explore.
The Food and Drug Administration's approval came after studies indicated the drug was effective in improving sexual performance in men with a history of coronary artery disease, and Cialis had the lowest risk of cardiovascular disease and stroke.
Pfizer's drug received final approval from the FDA in October 2010, and the company is also seeking approval to continue developing the drug. The company plans to conduct additional studies on the drug to determine whether it works better than Viagra in the U. S.
Read MoreIn January, the FDA granted Cialis's application for a tentative approval for treating erectile dysfunction. Cialis is the first drug to win FDA approval to treat erectile dysfunction and offers a new option for those who may have concerns about erectile dysfunction. Its approval will allow Cialis to remain effective for up to 36 months, allowing for its ability to continue to be a viable therapy for erectile dysfunction.
Cialis has had a "hardening" effect on blood flow to the penis, leading to a decrease in the size of the arteries that supply blood to the penis. The drug also has been linked to a decrease in testosterone levels, and may also increase the risk of other side effects such as a rare type of allergic reaction, which can cause dizziness and vision problems.
Cialis is also used off-label for the treatment of erectile dysfunction. The drug has been associated with a decreased rate of sexual performance, as well as the need to have sexual intercourse more than once per day. Cialis may also cause temporary and permanent visual or auditory memory loss, and may increase the risk of hearing loss or a hearing loss caused by hearing loss.
The drug's manufacturer, Pfizer Inc., filed for the FDA's approval in December 2009. The company's filing for the approval was prompted by a study that showed a 69% chance of men experiencing erectile dysfunction and a 57% chance of having erectile dysfunction, but it did not reach an FDA approval for the drug. The study was stopped on the basis of safety concerns and the FDA's approval was delayed until April 2012.
Cialis was developed to address erectile dysfunction and improve sexual performance in men who are using nitrates to treat heart failure and angina. The drug's active ingredient, tadalafil, works by increasing blood flow to the penis and its effects may be greater than Viagra, which is currently only available in a once-daily tablet.
In addition to Cialis, the company is also exploring other options to treat erectile dysfunction. The company plans to conduct studies on the drug to determine its effectiveness, and will also be working with regulatory authorities to initiate further studies to better understand how the drug affects the body and how it may affect a patient's health.
In June 2011, the FDA granted Cialis tentative approval for treatment of erectile dysfunction in men who are taking nitrates or nitric oxide donors to treat angina. The drug was developed as a treatment for erectile dysfunction and has not shown a significant increase in erectile function.
The drug was initially approved for the treatment of erectile dysfunction in men who have a history of heart failure. The drug was originally developed to treat heart failure but was later found to cause an increase in blood pressure. However, the FDA granted approval to the drug for its use in treating heart failure in men with a history of coronary artery disease.
The drug's manufacturer, Pfizer Inc., was also granted final approval for treating erectile dysfunction in men who have a history of angina.
Cialis has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Cialis use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
Read More This Side effects reported from Cialis use include: [ added at of 4/3]As with all prescription medications, inform your doctor if you are a male or female, if you are taking or where you are taking any other medications, including non-prescription products.
As with all prescription medications, be sure to have a comprehensive medical history, including any and all of the following: insurance coverage for Cialis, specific medical conditions, interactions with other medications, including prescription and over-the-counter drugs, and any drugs you’re currently taking.
Tell your doctor if you are taking any of the following medications: nitrates, isosorbide, nitroglycerin, mycophenolate, medications for smooth muscle disease, medications for chronic pain, certain antifungalants, HIV protease inhibitors, or high blood pressure medication.
As with all prescription medications, be sure to inform your doctor if you are a female, if you are taking insurance coverage for Cialis, specific medical conditions, interactions with other medications, including prescription and over-the-counter drugs, and any drugs you are currently taking.
As with all prescription medications, be sure to inform your doctor of any medical conditions you have, especially if you are a male or females.
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