Pfizer, Pfizer Inc., is developing a new drug to treat erectile dysfunction in men. The drug was named the best selling drug byThe New York Timesmagazine as well asThe Wall Street JournalandThe Los Angeles Times.
The U. S. Food and Drug Administration has approved a generic version of the drug in December. That version contains an equivalent dose of Viagra, Pfizer's blockbuster erectile dysfunction drug, while the brand-name drug is generic. The FDA approved the first generic version of the drug in April.
The new drug will be sold at a drugstore in New York, according to Pfizer spokesman Charles Burns. Burns said the company's first-quarter earnings totaled $11.2 million, up from $8.8 million, which Pfizer reported in January.
Pfizer was one of several drugmakers, including Mylan, to market the generic drug in the U. after an internal review by the FDA in May. Mylan said in a statement, "Our research and development efforts have been robust and continue to be consistent with the progress we've made in the past year and a half. Our products have been in use for more than 60 years and have been approved by the FDA as a prescription drug for the treatment of erectile dysfunction."
Mylan's product is Pfizer's blockbuster erectile dysfunction drug, but the drug has yet to be approved by the FDA for sale in the U. The drug is still under patent, but other drugmakers have filed a patent application with the FDA earlier this year to get the drug on the market. The patent on the drug is currently in litigation with the U. Food and Drug Administration.
Other drugmakers, including AstraZeneca, Bristol-Myers Squibb, Teva Pharmaceutical Industries Ltd., Johnson & Johnson and Novartis, have filed patents for the generic version of the drug.
Pfizer's other drug, Viagra, has yet to be approved by the FDA. Pfizer Inc. said in a statement that the company's U. patent application for Viagra will be "not yet approved." Viagra will likely have to be approved in the U. by the FDA in late April.
Pfizer said that since the drug's launch in the U. S., it is "not likely that we will be able to launch the generic version of Viagra without a patent application for the branded version."
Pfizer shares rose 7.8% to $26.10 on the New York Stock Exchange. The stock has nearly doubled in value since it reached $26.10 a day.
The Associated Press contributed to this report.
Copyright © The Times Union 2013
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THE WELL SITUATION’S first drug for erectile dysfunction, sildenafil, will be approved by the FDA in December, but it could take several years to get the drug in the U. Without a U. Food and Drug Administration approval, many patients are waiting for the little blue pill to become the most prescribed medication for the condition.
Sildenafil is one of the few prescription drugs that Pfizer has been able to launch. The drug has been available in generic versions since 1998, when Pfizer's patent expired. Viagra was first approved in 1998.
Viagra has been the best-selling prescription drug in the U. for many years, with more than $1 billion in worldwide sales last year, according to IMS Health, a health information company.
The drug is the latest drugmaker to launch a generic version of Viagra, the first of a new class of medications known as phosphodiesterase-5 (PDE5) inhibitors. PDE5 is the enzyme that breaks down cGMP in the penis, helping to relax blood vessels and allow blood to flow easily. The drug is also known as Viagra and works by relaxing the smooth muscle in the penis.
The generic sildenafil will be available by prescription only in the U. and is being developed to treat both conditions, according to the article.
Since the drug was approved in 1998, the FDA has approved two other PDE5 inhibitors: Viagra Connect and Cialis.
Viagra Connect is an effective treatment for erectile dysfunction (ED). Erectile dysfunction is a common problem that includes difficulty getting or keeping an erection. If you’re affected by erectile dysfunction, there is treatment and support available that can help, including medicines such as Viagra Connect.
If you have a low libido, understanding the cause of this and getting help to increase your libido, may change the way you think and feel about sex. There is support available that may help, including talking to a professional such as a psychologist or counsellor. Your doctor may be able to refer you for counselling, or you can.
Viagra Connect relaxes the blood vessels in the penis to increase blood flow. This means that you can get an erection when you’re sexually aroused. After sexual activity, your erection will go away as it normally would.
If you’ve decided to take Viagra Connect to treat your erection problems you should swallow one whole tablet with some water, about an hour before you want to have sex. Don’t take more than one tablet a day.,
Remember to read the instructions that come with the medicine carefully, or talk to a pharmacist or your GP if you’re not sure how to take Viagra Connect. They’ll be able to give you more information and support.
Viagra Connect isn’t suitable for everyone, including people with some other health conditions such as heart problems. Talk to your GP or a pharmacist about whether Viagra Connect is the best treatment option for you.
It usually takes about one hour for Viagra Connect to start working., Most people take one tablet about an hour before they want to have sex. But everyone is different and for some people, it may take more or less time to get an erection after taking Viagra Connect.
After sex, your erection should go away normally. If it doesn't, contact your GP, a pharmacist, or.
Once you've taken Viagra Connect, it will stay active for up to four hours.
Get emergency medical help if you doBefore taking Viagra Connect, your healthcare provider may need to:
Do not take more than theamount expected to work with the pharmacist or your GP. They may suggest that you consult a pharmacist or a medical professional before taking Viagra Connect.
Like all medicines, Viagra Connect can cause side effects, although not everybody gets them. If you experience any of these side effects, or are eligible for treatment, including erectile dysfunction (ED) (when you’re not allergic to sildenafil), will be monitored.
Side effects in can include:
Contact your doctor if you experience or notice any of the following:
This is not all the side effects this report has had a side effect on its way. For more information, see.
There is a medical - monitored version of the side effect collection available through the manufacturer website.
itamin C is converted from an enzyme calledphosphodiesterasein your body. This type of medication works much more quickly, and it’s easier to take than type 2 diabetes medicine.
The government’s latest move to extend a ban on the prescription drug Viagra is the latest example of a political move that could undermine the free market, a group of experts said Monday.
The Pharmaceutical Society of Australia, the trade association that represents the trade group, said it would not be the first time Australia has banned the use of Viagra as a treatment for erectile dysfunction.
But the pharmaceutical industry is expected to make an announcement in March about whether the drug can be bought over the counter, the group said.
“It would be the first time we are being asked to take any action for the benefit of the public,” said Dr Nachum Katlowitz, president of the trade association. He said the move would also protect the drug’s supply and supply chain.
The move was first announced by the Pharmaceutical Society of Australia in March as part of an international effort to tackle the widespread use of the erectile dysfunction drug in Australia, he said.
“This is a great move by the Pharmaceutical Society of Australia to protect the public from the dangers of buying the medicines in this country,” said Dr Katlowitz. He said it is also good to see Australia considering whether Viagra is now a safe and appropriate treatment for erectile dysfunction, which is often linked to erectile problems.
“It will be a great step to protect the public and to protect the public’s health.”
The trade association said it was in the process of negotiating a deal with the government to ensure that the drug is widely available.
“We will not be making a decision until we have reached an agreement with the government.”
The trade association said it was not aware of the government’s decision to delay the release of Viagra. The government has also not responded to Australian media reports of its decision.
“It will not be the first time Australia has made a public statement about the risk of the drugs being sold over the counter,” said the trade association. It is not clear whether the trade group has any policy or legal obligations to protect public health.
The trade association said it was not aware of any decision being made by Australia to allow Viagra to be sold without the approval of the government.The trade association said it was not aware of the decision to allow Viagra to be sold over the counter. It was also not aware of the government’s decision to delay the release of Viagra, the trade association said.
The trade association said it was not aware of any decision to allow the drug to be sold over the counter, including to increase the supply of the drug. It was not clear whether the government was aware of the decision.
The trade association said it was not aware of the government’s decision to allow Viagra to be sold over the counter. It was also not aware of the government’s decision to delay the release of Viagra.
“We are disappointed that Australia will not be doing its part to protect public health,” said the trade association. “It is important that the Australian government be aware of the potential harm that Viagra can cause to public health.”
Dr Katlowitz said the government was aware of the decision, but that it could not comment on the decision as it would not be the first time Australia had taken steps to protect public health.
MANILA, Philippines - A Philippine court has ordered the government to pay more than $100 million to resolve the sex trafficking case, which accused the country's sex industry and sex ring business of failing to warn about the risk of acquiring and selling unlicensed sexual performance enhancement drugs.
A total of more than 50,000 sex ring business and the Philippine Star's former sexual-performance-enhancing products group, PASO, purchased Viagra, the Philippines' first-ever prescription drug for erectile dysfunction.
The case, which was brought against the Philippines Food and Drug Administration (FDA) in 2008 and the Philippine Commission of Torts (PCTO), was investigated by the Manila International High Court.
"The government of the Philippines has committed itself to resolving the criminal and civil sex trade cases," Mr. Justice Baccarat, said on Monday.
Mr. Justice Baccarat said he was "very pleased" with the work of the PASO team and said it was important for the court to hear the case. He added that the PASO was also concerned that a judge may have allowed the company to continue the investigation and will make the decision as soon as possible.
Justice Baccarat said the government was entitled to have the cases investigated and prosecuted.
"This is a significant case that needs to be investigated and prosecuted and this investigation will continue to take place and result in a fair and timely trial for the people involved," he said.
The Philippines Food and Drug Administration, which is under investigation for violations of trade dress, is the first agency to be found guilty of importing and selling unlicensed products that are used in the industry, the Philippines government said.
"In the United States, the U. S. Food and Drug Administration (FDA) is the only regulator responsible for regulating drug products in the country," the agency said in a statement.
The FDA's investigation revealed that at least 30 of the sexual-performance-enhancing drugs purchased from PASO were sold in the country. The drugs included Viagra, Cialis, Levitra and Cialis-Rx, which are used for male sexual function.
The Philippines drug companies purchased these drugs at a price of $100 per tablet and had an estimated profit of $1.5 billion.
"We're deeply concerned," Mr. Justice Baccarat said.
"If a drug company is making a profit in this country, I don't know what to do," he added.
The company also purchased Levitra and Cialis for $3,500 each, which was then sold in the Philippines as a "pharmaceutical drug" and for $1.4 million, according to a company statement.
The Philippines drug companies were not asked to comment on how much the money will be distributed.
The company also reported on the government's investigation into the PASO case.
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