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Walgreens said in a regulatory filing Wednesday that it would add a health warning to Viagra's label for a generic version, which is currently sold as Cialis.
Walgreens said the application is "an application to the U. Food and Drug Administration (FDA) approved for sale," meaning Pfizer is the manufacturer.
The application will require the drugmaker to pay for a 90-day supply of the generic equivalent, which can then be sold to customers.
Walgreens said that it has submitted a request for a copy of the proposed approval and will submit it to the FDA once the proposal is submitted.
The FDA approved the drug to treat erectile dysfunction in men between the ages of 18 and 64, which is the most common sexual problem for men in the U.
The product, which comes in 50 mg and 100 mg tablets, treats the problem by improving blood flow to the penis, but it also helps men with other health issues who may be suffering from low blood pressure.
A generic version of the drug will be available through the end of this year, and it is expected to be available in several languages.
Walgreens said it has "several prior approvals" for the drug, including a case of Viagra, and that it is currently "reviewing" the application for "potentially other approved pharmaceutical products."
The company also said it is working with other drugmakers to promote the product's safety and effectiveness in both men and women.
Walgreen, which represents more than 30 million U. consumers, said in a statement Tuesday it is "reviewing and implementing a product evaluation and safety plan for all consumers."
It said the plan would include "consideration of current safety data for all eligible customers and guidance on how to enhance the risk/benefit profile of each prescription drug."
It said that the company would also include information on prescription drug benefits, including those related to erectile dysfunction and other health conditions. That information would be available in the FDA-approved label information within the next five years.
Walgreen said it has taken several months to review and approve a generic version of Viagra, known as Cialis, based on the company's safety and effectiveness data.According to Pfizer, the company will receive final approval from the FDA in late March, after which it may begin selling the generic version as soon as April. Pfizer also has an initial plan to sell the generic product in a more favorable market, according to Pfizer.
Walgreen said it had "great faith in the drug company" and is "excellent at selling prescription drugs."
Pfizer's FDA-approved erectile dysfunction medication Cialis, which treats erectile dysfunction, also treats benign prostatic hyperplasia (BPH), or enlarged prostate gland, which is a condition in which the prostate gland becomes more painful and difficult to urinate.
The FDA approved the drug Thursday to treat both conditions.
In a statement, Pfizer said that the company will continue to "review and implement a product evaluation and safety plan" for all customers. It will also include "implementation of the FDA approved safety information for all eligible customers and guidance on how to enhance the risk/benefit profile of each prescription drug."
Pfizer's announcement comes just days after a similar application was filed by Eli Lilly and Company, which has already received regulatory approval for its blockbuster drug, Vardenafil, which treats erectile dysfunction. The company was criticized for its aggressive marketing tactics and for "not implementing the FDA safety guidance."
The FDA has twice rejected applications for Viagra and Cialis.
Walgreens said in a statement that it has taken several months to review and approve a generic version of Viagra, known as Cialis.
Walgreens, which represents more than 30 million U. consumers, said in a regulatory filing Wednesday that it would add a health warning to Viagra's label for a generic version, which is currently sold as Cialis.The London-based drugmaker will soon start selling its anti-impotence drug Viagra, which it hopes will be used to boost sex drive in men.
The erectile dysfunction pill is used to treat erectile dysfunction in men, but it is not widely known as a drug to treat impotence.
Viagra is the brand name for the medicine sildenafil, which works by blocking an enzyme in the penis to improve blood flow. It is available as a pill and as an oral liquid.
But some experts say it could soon become the first-line treatment for erectile dysfunction.
Doctors say it's safe to use, and Viagra will be available in pharmacies as a cheaper alternative.
Viagra, which was launched by Pfizer in 1998, is the first oral treatment for erectile dysfunction in the UK.
It's also one of Pfizer's most popular drugs, with more than 20 million prescriptions a year.
The erectile dysfunction pill will be available to people 18 and older by next month, with a maximum limit of 30 per month.
Dr Laura Squire, chief executive of New York-based Pfizer, said: "It's not a drug to help men achieve and maintain an erection, but it is a potentially useful drug that can help men get back on their feet in a very safe and effective way."
The erectile dysfunction drug, which is sold under the brand name Viagra, is also called sildenafil. It works by blocking an enzyme in the body that causes blood flow to the penis.
Doctors usually prescribe the drug for men who have difficulty achieving or maintaining an erection, such as those suffering from angina, an enlarged heart and high blood pressure, or who have experienced an erection before. It's also known as "the pill".
Viagra will be available to the general public in pharmacies as a cheaper alternative to its branded counterpart, Cialis.
Dr David Jones, a clinical pharmacologist at the London-based drugmaker, said the company was "very excited" to begin selling its Viagra.
"We believe it will revolutionise the way we do medicines, improve our patients' experience and we're very confident that the launch of this drug will provide people with a much-needed, affordable option to treat their condition."
It's the first oral treatment for erectile dysfunction in the UK, following the release of an online questionnaire about sexual health.
In April, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK began investigating whether the drug could help men with erectile dysfunction.
MHRA has not yet confirmed that the drug is a direct treatment for erectile dysfunction. But the agency said that "as with all other medicines, it is important to consult with a healthcare professional before starting any new treatment".
Men who are advised to use an oral treatment for erectile dysfunction have a higher chance of achieving and maintaining an erection when prescribed by their doctor.
There is little evidence that Viagra will increase the number of men who suffer from erectile dysfunction.
Men who experience premature ejaculation have a slightly lower chance of achieving and maintaining an erection when prescribed by their doctor.
A study by the Royal Pharmaceutical Society (RPS) found that Viagra was not as effective as Cialis, which was used as a treatment for impotence.
The MHRA has said that the drug is safe and effective for most men, but it is important to talk to a doctor before taking the drug.
Viagra is available in pharmacies as a cheaper alternative to Cialis. It has been available in the UK since 1999.
The UK's health ministry, Health Secretary Alex Azar, told the Sunday Express newspaper: "We are confident that it will give men who may have experienced impotence the highest number of patients and give them the option of a cheaper, more effective treatment."
Mick Foy, executive director of the National Association of Boards of Pharmacy, said Viagra's efficacy has been supported by research and the results have also been published in peer-reviewed journals.He said: "It has been shown to be effective in helping to improve sexual health and the overall quality of life of men with impotence. In some men it has even been shown to have a positive impact on sexual satisfaction and performance.
Sildenafil citrate, commonly known by the brand name, is a prescription-only medicine used to treat erectile dysfunction (ED) in adult men. It works by improving blood flow to the penis, helping to achieve and maintain an erection during sexual activity.
Sildenafil is available in 25mg, 50mg, and 100mg strengths.
Sildenafil has been shown to be effective in up to 80% of men with ED, with effects typically noticeable within 30 to 60 minutes, and lasting for up to 4–5 hours.
Common side effects include:
Less common but serious effects include visual disturbances, hearing changes, or prolonged erections. Seek medical attention if severe or persistent side effects occur.
Sildenafil should not be used by those:
Inform your doctor of all medications and supplements before use. Interactions may occur with:
Avoid excessive alcohol while taking sildenafil, as it can lower blood pressure and increase side effect risk. Use with caution if you have any heart-related conditions.
Sildenafil is available by prescription only in the UK.
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